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Retrospective Transoral Incisionless Fundoplication (TIF) Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
EndoGastric Solutions
ClinicalTrials.gov Identifier:
NCT01327963
First received: March 30, 2011
Last updated: March 31, 2011
Last verified: March 2011
History of Changes
  Purpose

The purpose of this open-label, postmarket study is to evaluate the safety and efficacy of transoral incisionless fundoplication (TIF) performed with EsophyX in a broad range of gastroesophageal reflux disease (GERD) patients treated at high volume centers across the United States.


Condition Intervention Phase
Gastroesophageal Reflux Disease
 Device: Transoral Incisionless Fundoplication (EsophyX)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Outcomes After Transoral Incisionless Fundoplication (TIF) Performed in Routine Clinical Practice: The Retro TIF Study

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by EndoGastric Solutions:

Primary Outcome Measures:
  • Typical and atypical Gastroesophageal Reflux Disease (GERD) symptom elimination [ Time Frame: 12 or 24 months ] [ Designated as safety issue: No ]
    Typical and atypical GERD symptom elimination (scores ≤ 2 to each question in GERD Health-related Quality of Life (GERD-HRQL), GERD Symptom Score (GERSS) and Reflux Symptom Index (RSI) questionnaires) at the follow-up.


Secondary Outcome Measures:
  • Serious Adverse Events (SAEs) & Unanticipated Adverse Device Effects (UADEs) [ Time Frame: 12 or 24 months ] [ Designated as safety issue: Yes ]
    The treatment will be considered safe if the incidence of serious adverse events (SAEs) is below the ranges reported for laparoscopic fundoplication.

  • Elimination of Proton Pump Inhibitors (PPIs) use [ Time Frame: 12 or 24 months ] [ Designated as safety issue: No ]
    Complete discontinuation will be considered clinically significant.

  • Healing of reflux esophagitis [ Time Frame: 12 or 24 months ] [ Designated as safety issue: No ]
    One grade reduction will be considered clinically significant.

  • Reduction of hiatal hernia [ Time Frame: 12 or 24 months ] [ Designated as safety issue: No ]
    Size reduction to < 1 cm will be considered clinically significant.

  • Normalization or clinically significant improvement in esophageal acid exposure and reflux episodes [ Time Frame: 12 or 24 months ] [ Designated as safety issue: No ]
    Esophageal acid exposure will be measured objectively by 48-hour Bravo pH or 24-hour impedance/pH testing at the follow-up (where pH testing is available). Normalization of esophageal acid exposure will be defined by total time with pH < 4 for ≤ 6% of 24-hour or for ≤ 5.3% of 48-hour monitoring period. The number of reflux episodes of ≤ 44 per each 24-hour period will be considered normal.


Estimated Enrollment: 180
Study Start Date: September 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Transoral Incisionless Fundoplication (EsophyX)
    Transoral incisionless esophago-gastric fundoplication performed using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following the standardized TIF2 protocol.
    Other Names:
    • Transoral Incisionless Fundoplication
    • TIF
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-85 years
  • Have undergone the TIF procedure within the past 2 years
  • Availability for a follow-up visit at 12 or 24 months
  • Willingly and cognitively signed informed consent

Exclusion Criteria:

  • Procedure not completed or performed following a non-standardized TIF protocol
  • Subjects suffering from other GI conditions such as dyspepsia, celiac disease, IBS or Crohn's disease
  • Pregnancy
  • Enrollment in another device or drug study that may confound the results
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327963

Locations
United States, Indiana
Saint Mary Medical Center
Hobart, Indiana, United States, 46342
United States, Kentucky
Livingston Hospital and Healthcare Services, Inc. CAH
Salem, Kentucky, United States, 42078
United States, Michigan
Allegan Surgical Associates, P.C.
Allegan, Michigan, United States, 49010
United States, Texas
Ihde Surgical Group, PA
Arlington, Texas, United States, 76014
United States, Virginia
Reston Surgical Associates
Reston, Virginia, United States, 20190
Sponsors and Collaborators
EndoGastric Solutions
  More Information

No publications provided

Responsible Party: Emir Deljkich/Medical Affairs Manager & MSL, EndoGastric Solutions
ClinicalTrials.gov Identifier: NCT01327963     History of Changes
Other Study ID Numbers: D01079
Study First Received: March 30, 2011
Last Updated: March 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by EndoGastric Solutions:
Gastroesophageal reflux disease
GERD
Heartburn
Reflux
 Regurgitation
Hoarseness
Cough

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013