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Endoscopic Fundoplication With MUSE System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669874
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Pier Alberto Testoni, IRCCS San Raffaele

Brief Summary:

This is a spontaneous, prospective, monocentric, observational, cohort study, with the aim of evaluating the effect of ultrasound-guided endoscopic fundoplication using the Medigus Ultrasonic Surgical Endostapler (MUSESystem; MediGus, Ltd. Israel) in patients with esophageal or extra-esophageal gastro-oesophageal reflux disease (GERD)-related symptoms. The end of the study will be at the end of the 6-year follow-up of the last patient enrolled. The study proposes the following objectives:

  • Primary objective: to evaluate the efficacy of endoscopic fundoplication with MUSE for the treatment of GERD, through clinical experience, in terms of:

    • effect on GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaire scores
    • effect on the use and dosage of proton pump inhibitors (PPI)
    • feasibility and safety of the endoluminal fundoplication procedure
  • Secondary objective: to characterize the treated patient population (demographic and objective data) and to identify the successful predictors of the procedure.

The study design includes the following phases:

*Preliminary patient evaluation and verification of inclusion criteria through: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI

  • 6-month follow-up: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
  • 12-months follow-up: Upper GI endoscopy 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
  • Yearly clinical follow-up (up to 6 years):

PPI use GERD-HRQL and RSI questionnaires scores OFF PPI


Condition or disease Intervention/treatment
Gastro-esophageal Reflux Endoscopic Fundoplication Device: Endoscopic fundoplication

Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Application of MUSE System for Ultrasound-guided Endoscopic Fundoplication for Gastro-esophageal Reflux Disease Patients
Actual Study Start Date : September 16, 2015
Estimated Primary Completion Date : September 16, 2021
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy GERD


Intervention Details:
  • Device: Endoscopic fundoplication

    Endoscopic fundoplication is a less invasive alternative to the traditional surgical fundoplication.

    The MUSE device is similar to an endoscope, so the whole procedure can be done by a single operator. The device is composed of a shaft with a distal rigid part which is placed in the esophagus 3 cm proximal to the esophago-gastric junction containing a cartridge holding five B-shaped titanium surgical Staples and a tip which is retroflexed and contains an ultrasonic transducer which defines the correct tissue thickness for stapling the fundus against the esophagus. The device must be extracted to be reloaded with 5 more staples at a time for creation of a 180° anterior fundoplication.



Primary Outcome Measures :
  1. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [ Time Frame: change from baseline GERD-HRQL at 6 months ]
    GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.

  2. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [ Time Frame: change from baseline GERD-HRQL at 12 months ]
    GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.

  3. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [ Time Frame: change from baseline GERD-HRQL at 24 months ]
    GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.

  4. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [ Time Frame: change from baseline GERD-HRQL at 3 years ]
    GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.

  5. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [ Time Frame: change from baseline GERD-HRQL at 4 years ]
    GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.

  6. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [ Time Frame: change from baseline GERD-HRQL at 5 years ]
    GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.

  7. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [ Time Frame: change from baseline GERD-HRQL at 6 years ]
    GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.

  8. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [ Time Frame: change from baseline RSI at 6 months ]
    RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.

  9. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [ Time Frame: change from baseline RSI at 12 months ]
    RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.

  10. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [ Time Frame: change from baseline RSI at 24 months ]
    RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.

  11. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [ Time Frame: change from baseline RSI at 3 years ]
    RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.

  12. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [ Time Frame: change from baseline RSI at 4 years ]
    RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.

  13. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [ Time Frame: change from baseline RSI at 5 years ]
    RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.

  14. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [ Time Frame: change from baseline RSI at 6 years ]
    RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.

  15. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption [ Time Frame: change from baseline PPI consumption at 6 months ]
    Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy

  16. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption [ Time Frame: change from baseline PPI consumption at 12 months ]
    Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy

  17. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption [ Time Frame: change from baseline PPI consumption at 24 months ]
    Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy

  18. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption [ Time Frame: change from baseline PPI consumption at 3 years ]
    Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy

  19. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption [ Time Frame: change from baseline PPI consumption at 4 years ]
    Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy

  20. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption [ Time Frame: change from baseline PPI consumption at 5 years ]
    Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy

  21. To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption [ Time Frame: change from baseline PPI consumption at 6 years ]
    Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy


Secondary Outcome Measures :
  1. To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size [ Time Frame: change from baseline hiatal hernia size at 6 months ]
    Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The size of a hiatal hernia is a parameter describing the continence characteristics of the sphincter neo-valve.

  2. To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size [ Time Frame: change from baseline hiatal hernia size at 12 months ]
    Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The size of a hiatal hernia is a parameter describing the continence characteristics of the sphincter neo-valve.

  3. To identify endoscopic factors predicting positive outcomes: changes in Hill's grade [ Time Frame: change from baseline Hill's grade at 6 months ]
    Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Hill's grade is a parameter describing the continence characteristics of the sphincter neo-valve. The Hill's grade range from I to IV; the higher grades represents worse outcomes (worse valve's continence).

  4. To identify endoscopic factors predicting positive outcomes: changes in Hill's grade [ Time Frame: change from baseline Hill's grade at 12 months ]
    Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Hill's grade is a parameter describing the continence characteristics of the sphincter neo-valve. The Hill's grade range from I to IV; the higher grades represents worse outcomes (worse valve's continence).

  5. To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght [ Time Frame: change from baseline Jobe's lenght at 6 months ]
    Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Jobe's lenght is a parameter describing the continence characteristics of the sphincter neo-valve.

  6. To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght [ Time Frame: change from baseline Jobe's lenght at 12 months ]
    Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Jobe's lenght is a parameter describing the continence characteristics of the sphincter neo-valve.

  7. To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade [ Time Frame: change from baseline esophagitis' grade at 6 months ]
    Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The presence of esophagitis and its grade, as defined by the Los Angeles classification, is a parameter of procedure's efficacy. The esophagitis grade range from A to D; the higher grades represents worse outcomes.

  8. To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade [ Time Frame: change from baseline esophagitis' grade at 12 months ]
    Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The presence of esophagitis and its grade, as defined by the Los Angeles classification, is a parameter of procedure's efficacy. The esophagitis grade range from A to D; the higher grades represents worse outcomes.

  9. To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score [ Time Frame: change from baseline DeMeester score at 6 months ]
    parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux. DeMeester score is a composite score which examined six variables (number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position). A score of >14.72 shows a pathological reflux. Higher values represent worse outcomes.

  10. To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score [ Time Frame: change from baseline DeMeester score at 12 months ]
    parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux. DeMeester score is a composite score which examined six variables (number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position). A score of >14.72 shows a pathological reflux. Higher values represent worse outcomes.

  11. To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time) [ Time Frame: change from baseline AET at 6 months ]
    parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  12. To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time) [ Time Frame: change from baseline AET at 12 months ]
    parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  13. To identify pathophysiological factors predicting positive outcomes: changes in longest reflux episode (min) [ Time Frame: change from baseline longest reflux episode at 6 months ]
    parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  14. To identify pathophysiological factors predicting positive outcomes: changes in longest reflux episode (min) [ Time Frame: change from baseline longest reflux episode at 12 months ]
    parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  15. To identify pathophysiological factors predicting positive outcomes: changes in number of refluxes greater than 5 minutes [ Time Frame: change from baseline number of refluxes greater than 5 minutes at 6 months ]
    parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  16. To identify pathophysiological factors predicting positive outcomes: changes in number of refluxes greater than 5 minutes [ Time Frame: change from baseline number of refluxes greater than 5 minutes at 12 months ]
    parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  17. To identify pathophysiological factors predicting positive outcomes: changes in number of total refluxes [ Time Frame: change from baseline number of total refluxes at 6 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  18. To identify pathophysiological factors predicting positive outcomes: changes in number of total refluxes [ Time Frame: change from baseline number of total refluxes at 12 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  19. To identify pathophysiological factors predicting positive outcomes: changes in number of acid refluxes [ Time Frame: change from baseline number of acid refluxes at 6 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  20. To identify pathophysiological factors predicting positive outcomes: changes in number of acid refluxes [ Time Frame: change from baseline number of acid refluxes at 12 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  21. To identify pathophysiological factors predicting positive outcomes: changes in number of weakly acid refluxes [ Time Frame: change from baseline number of weakly acid refluxes at 6 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  22. To identify pathophysiological factors predicting positive outcomes: changes in number of weakly acid refluxes [ Time Frame: change from baseline number of weakly acid refluxes at 12 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  23. To identify pathophysiological factors predicting positive outcomes: changes in number of not acid refluxes [ Time Frame: change from baseline number of not acid refluxes at 6 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  24. To identify pathophysiological factors predicting positive outcomes: changes in number of not acid refluxes [ Time Frame: change from baseline number of not acid refluxes at 12 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  25. To identify pathophysiological factors predicting positive outcomes: changes in number of proximal refluxes [ Time Frame: change from baseline number of proximal refluxes at 6 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  26. To identify pathophysiological factors predicting positive outcomes: changes in number of proximal refluxes [ Time Frame: change from baseline number of proximal refluxes at 12 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  27. To identify pathophysiological factors predicting positive outcomes: changes in MNBI (Mean Nocturnal Baseline Impedance) [ Time Frame: change from baseline MNBI at 6 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  28. To identify pathophysiological factors predicting positive outcomes: changes in MNBI (Mean Nocturnal Baseline Impedance) [ Time Frame: change from baseline MNBI at 12 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  29. To identify pathophysiological factors predicting positive outcomes: changes in PSPW (Post Swallow reflux-induced Peristaltic Waves) [ Time Frame: change from baseline PSPW at 6 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  30. To identify pathophysiological factors predicting positive outcomes: changes in PSPW (Post Swallow reflux-induced Peristaltic Waves) [ Time Frame: change from baseline PSPW at 12 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  31. To identify pathophysiological factors predicting positive outcomes: changes in BCT (Bolus Clearance Time) [ Time Frame: change from baseline BCT at 6 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  32. To identify pathophysiological factors predicting positive outcomes: changes in BCT (Bolus Clearance Time) [ Time Frame: change from baseline BCT at 12 months ]
    parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.

  33. To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) basal pressure [ Time Frame: change from baseline LES basal pressure at 6 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.

  34. To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) basal pressure [ Time Frame: change from baseline LES basal pressure at 12 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.

  35. To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) lenght [ Time Frame: change from baseline LES lenght at 6 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.

  36. To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) lenght [ Time Frame: change from baseline LES lenght at 12 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.

  37. To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) IRP (Integrated Relaxation Pressure) [ Time Frame: change from baseline LES IRP at 6 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.

  38. To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) IRP (Integrated Relaxation Pressure) [ Time Frame: change from baseline LES IRP at 12 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.

  39. To identify pathophysiological factors predicting positive outcomes: changes in DCI (Distal Contractile Integral) [ Time Frame: change from baseline DCI at 6 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.

  40. To identify pathophysiological factors predicting positive outcomes: changes in DCI (Distal Contractile Integral) [ Time Frame: change from baseline DCI at 12 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.

  41. To identify pathophysiological factors predicting positive outcomes: changes in rate of peristaltic waves [ Time Frame: change from baseline rate of peristaltic waves at 6 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.

  42. To identify pathophysiological factors predicting positive outcomes: changes in rate of peristaltic waves [ Time Frame: change from baseline rate of peristaltic waves at 12 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.

  43. To identify pathophysiological factors predicting positive outcomes: changes in rate of weak waves [ Time Frame: change from baseline rate of weak waves at 6 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.

  44. To identify pathophysiological factors predicting positive outcomes: changes in rate of weak waves [ Time Frame: change from baseline rate of weak waves at 12 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.

  45. To identify pathophysiological factors predicting positive outcomes: changes in rate of fragmented waves [ Time Frame: change from baseline rate of fragmented waves at 6 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.

  46. To identify pathophysiological factors predicting positive outcomes: changes in rate of fragmented waves [ Time Frame: change from baseline rate of fragmented waves at 12 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.

  47. To identify pathophysiological factors predicting positive outcomes: changes in rate of failed waves [ Time Frame: change from baseline rate of failed waves at 6 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.

  48. To identify pathophysiological factors predicting positive outcomes: changes in rate of failed waves [ Time Frame: change from baseline rate of failed waves at 12 months ]
    parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients are selected from tertiary care center
Criteria

Inclusion Criteria:

  • Chronic (> 6 months) GERD-related esophageal or extra-esophageal symptoms
  • Endoscopic or pH-impedance evidence of GERD (esophagitis, Barrett's esophagus, NERD, hypersensitive esophagus)
  • Indication to surgical fundoplication
  • Patients available for a long-term follow-up

Exclusion Criteria:

  • Hiatal hernia ≥ 3 cm
  • Major esophageal motility disorder
  • Esophageal stenosis
  • Malignant neoplasia (except minor superficial skin neoplasm)
  • Portal hypertension, bleeding disorders so to controindicate surgery, esophageal varices, stenosis or diverticula
  • Previous cardiac, thoracic or upper GI surgery
  • BMI >40
  • Pregnancy or breast feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669874


Contacts
Layout table for location contacts
Contact: Pier Alberto Testoni, Professor +390226432756 testoni.pieralberto@hsr.it

Locations
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Italy
Pier Alberto Testoni Recruiting
Milan, Italy, 20132
Contact: Pier Alberto Testoni, MD    00390226432756      
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Layout table for investigator information
Principal Investigator: Pier Alberto Testoni, Professor San Raffaele Scientific Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pier Alberto Testoni, Professor, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT03669874    
Other Study ID Numbers: MUSE/2015
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases