Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by EndoGastric Solutions
Sponsor:
Information provided by (Responsible Party):
EndoGastric Solutions
ClinicalTrials.gov Identifier:
NCT01110811
First received: April 23, 2010
Last updated: February 10, 2014
Last verified: May 2013
  Purpose

The study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients compared with sham procedure.


Condition Intervention Phase
Gastroesophageal Reflux Disease
Hiatal Hernia
Device: Transoral Incisionless Fundoplication (TIF)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Transoral Incisionless Fundoplication (TIF) Using EsophyX With Sham Procedure for the Treatment of PPI Dependent GERD: the TIF vs. Sham Study

Resource links provided by NLM:


Further study details as provided by EndoGastric Solutions:

Primary Outcome Measures:
  • Proportion of patients in clinical remission [ Time Frame: at 6 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in symptoms [ Time Frame: at 6 moths follow-up ] [ Designated as safety issue: No ]
  • Normalized esophageal acid exposure [ Time Frame: at 6 months follow-up ] [ Designated as safety issue: No ]
  • Healed reflux esophagitis [ Time Frame: at 6 months follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TIF procedure
Transoral incisionless esophago-gastric fundoplication using the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) and following TIF2.0 protocol.
Device: Transoral Incisionless Fundoplication (TIF)
The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degress around the esophagus.
Sham Comparator: Sham procedure
Sham procedure consisting of upper GI endoscopy
Device: Transoral Incisionless Fundoplication (TIF)
The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degress around the esophagus.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-80 years
  • On daily PPIs for > 6 months
  • Documented PPI dependency
  • Persistent GERD symptoms without PPI therapy during the titration phase of the study
  • Evidence of two or more of the following while off PPI therapy (> 10 days):
  • Erosive esophagitis (Los Angeles grade A-C)
  • Abnormal ambulatory pH study
  • Moderate to severe GERD symptoms
  • Normal or near normal esophageal motility (by manometry)
  • Patient willing to cooperate with post-operative dietary recommendations and assessment tests
  • Signed informed consent

Exclusion Criteria:

  • BMI > 35
  • Hiatal hernia > 3 cm
  • Esophagitis LA grade D
  • Esophageal ulcer
  • Esophageal stricture
  • Barretts esophagus (Prague: C>1, M>2)
  • Esophageal motility disorder
  • Severe gastric paralysis
  • Pregnancy or plans for pregnancy in the next 12 months
  • 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
  • Severe 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110811

Contacts
Contact: Lars Lundell, M.D. +46 8 585 805 49 Lars.lundell@karolinska.se

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium
Principal Investigator: Jan Tack, M.D.         
Sub-Investigator: Raf Bisschops, M.D.         
France
University of Nantes Hospital Recruiting
Nantes, France
Principal Investigator: Jean-Paul Galmiche, M.D.         
Sub-Investigator: Emmanuel Coron, M.D.         
Sweden
Karolinska University, Huddinge Hospital Recruiting
Stockholm, Sweden
Principal Investigator: Lars Lundell, M.D.         
Karolinska University, Ersta Hospital Recruiting
Stockholm, Sweden
Principal Investigator: Anders Thorell, M.D.         
Sub-Investigator: Madeleine Montgomery, M.D.         
Principal Investigator: Bengt Hakanson, M.D.         
Sponsors and Collaborators
EndoGastric Solutions
Investigators
Principal Investigator: Lars Lundell, M.D. Karolinska University, Huddinge Hospital, Stockholm, Sweden
  More Information

No publications provided

Responsible Party: EndoGastric Solutions
ClinicalTrials.gov Identifier: NCT01110811     History of Changes
Other Study ID Numbers: D2009-10
Study First Received: April 23, 2010
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration
Sweden: Institutional Review Board
Sweden: Swedish Research Council
Belgium: Ethics Committee
France: Institutional Ethical Committee
France: Ministry of Health
Italy: Ethics Committee
Italy: Ministry of Health

Keywords provided by EndoGastric Solutions:
GERD
Esophagitis
Fundoplication
Anti-reflux surgery
PPI dependent

Additional relevant MeSH terms:
Gastroesophageal Reflux
Hernia, Hiatal
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hernia, Diaphragmatic
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 18, 2014