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Evaluation of the Safety and Effectiveness of Tailored Transoral Incisionless Fundoplication (TIF) Using EsophyX for the Treatment of GERD

This study has been withdrawn prior to enrollment.
(No funding source for device purchasing)
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
Daniel Birch, University of Alberta
ClinicalTrials.gov Identifier:
NCT01025739
First received: December 2, 2009
Last updated: September 18, 2011
Last verified: September 2011
History of Changes
  Purpose

Objectives of the Study:

The primary objective of this study is to evaluate the relative merits, safety and effectiveness of the tailored TIF2 procedure in treating GERD patients who have persistent GERD symptoms despite PPI therapy.

The secondary objective of the study is to evaluate the effectiveness of the tailored TIF procedure in restoring the antireflux barrier and eliminating GE reflux.

Type of Study:

Prospective, non-randomized, uncontrolled Study Duration 12 months Number of Patients 20

Inclusion Criteria:

Age 18-70 years, on daily PPIs for > 6 months, persistent GERD symptoms despite PPI therapy, anatomic disruption of the gastroesophageal valve to a Hill Grade II-III, evidence of one of the following while on PPI therapy: (1) erosive esophagitis (erosions or ulcerations during endoscopy); (2) abnormal ambulatory pH study; or (3) biopsy confirmed changes characteristic of reflux esophagitis; acceptable esophageal motility (by either manometry or video esophagogram), hiatal hernia no larger than 2 cm, patient willing to cooperate with post-operative dietary recommendations and assessment tests, signed informed consent

Exclusion Criteria:

BMI > 40, hiatal hernia > 2 cm, esophagitis grade D, esophageal ulcer, fixed esophageal stricture, gastric motility disorders, previous splenectomy, pregnancy (female), immunosuppression, ASA > 2, portal hypertension and/or varices, history of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis, active gastro-duodenal ulcer disease, gastric outlet obstruction or stenosis, gastroparesis or delayed gastric emptying, coagulation disorders

Interventions:

Treatment: Tailored transoral incisionless fundoplication (TIF2) using EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA)

Evaluation Criteria:

Primary Outcome Measure 24 hour pH impedance study: change in Johnson DeMeester scores; GERD-HRQOL scores Secondary Outcome Measures PPI usage, GERD symptoms at 6 and 12 months vs. baseline off PPI's, total number of reflux episodes, and Symptom Association Probability while off PPI.

Safety: Adverse events will be mapped to standard terms and reported.


Condition Intervention Phase
Gastroesophageal Reflux Disease (GERD)
 Device: EsophyX™ system with SerosaFuse fasteners
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Evaluation of the Safety and Effectiveness of Tailored Transoral Incisionless Fundoplication (TIF) Using EsophyX for the Treatment of GERD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 24 hour pH impedance study: change in Johnson DeMeester scores; GERD-HRQOL scores [ Time Frame: 1, 3, 6, 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PPI usage, GERD symptoms at 6 and 12 months vs. baseline off PPI's, total number of reflux episodes, and Symptom Association Probability while off PPI. Safety: Adverse events will be mapped to standard terms and reported. [ Time Frame: 1 day; 1 week; 1, 3, 6, 12 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: EsophyX™ system with SerosaFuse fasteners
    The EsophyX™ system with SerosaFuse fasteners (EndoGastric Solutions, Redmond, WA, USA) was designed to reconstruct the gastroesophageal junction through anterior partial fundoplication with tailored delivery of multiple fasteners during a single-device insertion.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-70 years
  • On daily PPIs for > 6 months
  • Persistent GERD symptoms despite PPI therapy
  • Anatomic disruption of the gastroesophageal valve to a Hill Grade II-III

  • Evidence of one of the following while on PPI therapy:

    • Erosive esophagitis (erosions or ulcerations during endoscopy)
    • Abnormal ambulatory pH study
    • Biopsy confirmed changes characteristic of reflux esophagitis
  • Acceptable esophageal motility (by either manometry or video esophagogram)
  • Hiatal hernia no larger than 2 cm
  • Patient willing to cooperate with post-operative dietary recommendations and assessment tests
  • Signed informed consent

Exclusion Criteria:

  • BMI > 40
  • Hiatal hernia > 2 cm
  • Esophagitis grade D
  • Esophageal ulcer
  • Esophageal stricture
  • Esophageal motility disorder
  • Prior splenectomy
  • Pregnancy or plans for pregnancy in the next 12 months (in females)
  • Immunosuppression
  • ASA > 2
  • Portal hypertension and/or varices
  • History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
  • Active gastro-duodenal ulcer disease
  • Gastric outlet obstruction or stenosis
  • Gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment
  • Coagulation disorders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025739

Locations
Canada, Alberta
CAMIS, Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Sponsors and Collaborators
University of Alberta
Alberta Health Services
  More Information

Publications:
Moss SF, Kidd M, Modlin IM. The status of the hiatus: the role of hernia in gastroesophageal reflux disease. J Clin Gastroenterol 2007;41:S144-S153

Responsible Party: Daniel Birch, MSc, MD, FRCSC, FACS, University of Alberta
ClinicalTrials.gov Identifier: NCT01025739     History of Changes
Other Study ID Numbers: Pro00004475
Study First Received: December 2, 2009
Last Updated: September 18, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Gastroesophageal Reflux Disease (GERD)
EsophyX

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 19, 2013