Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD) - Full Text View

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:

MedlinePlus related topics: GERD Hernia Hiatal Hernia

U.S. FDA Resources

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
Experimental: TIF procedure TIF procedure using EsophyX	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

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:	May 8, 2013
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
Hernia, Diaphragmatic
Hernia, Hiatal
Esophageal Motility Disorders

Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 18, 2013