Overview

This trial is active, not recruiting.

Conditions gastroesophageal reflux disease, hiatal hernia
Treatment transoral incisionless fundoplication (tif)
Phase phase 4
Sponsor EndoGastric Solutions
Start date April 2010
End date September 2015
Trial size 60 participants
Trial identifier NCT01110811, D2009-10

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Transoral Incisionless Fundoplication (TIF)
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 consisting of upper GI endoscopy
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.

Primary Outcomes

Measure
Proportion of patients in clinical remission
time frame: at 6 month follow-up

Secondary Outcomes

Measure
Reduction in symptoms
time frame: at 6 moths follow-up
Normalized esophageal acid exposure
time frame: at 6 months follow-up
Healed reflux esophagitis
time frame: at 6 months follow-up

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

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
Principal investigator Lars Lundell, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by EndoGastric Solutions.