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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
EndoGastric Solutions Identifier:
First received: April 23, 2010
Last updated: August 31, 2015
Last verified: August 2015
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
Procedure: Transoral Incisionless Fundoplication (TIF)
Phase 4

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: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TIF procedure
Transoral Incisionless Fundoplication (TIF)
Procedure: 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
Procedure: 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.

Detailed Description:

Primary Effectiveness Endpoint: The proportion of patients in clinical remission after 6 months (without being classified as treatment failure).

Secondary Effectiveness: PPI consumption, esophageal acid exposure, reduction in QOLRAD and GSRS scores and healing of reflux esophagitis.


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

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
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Please refer to this study by its identifier: NCT01110811

University Hospitals Leuven
Leuven, Belgium
University of Nantes Hospital
Nantes, France
Karolinska University, Ersta Hospital
Stockholm, Sweden
Karolinska University, Huddinge Hospital
Stockholm, Sweden
Sponsors and Collaborators
EndoGastric Solutions
Principal Investigator: Lars Lundell, M.D. Karolinska University, Huddinge Hospital, Stockholm, Sweden
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: EndoGastric Solutions Identifier: NCT01110811     History of Changes
Other Study ID Numbers: D2009-10 
Study First Received: April 23, 2010
Last Updated: August 31, 2015
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:
Anti-reflux surgery
PPI dependent

Additional relevant MeSH terms:
Gastroesophageal Reflux
Hernia, Hiatal
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Hernia, Diaphragmatic
Pathological Conditions, Anatomical processed this record on May 26, 2016