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 May 2010
End date June 2015
Trial size 500 participants
Trial identifier NCT01118585, D00960


The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Transoral incisionless fundoplication procedure using the 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 degrees around the esophagus.

Primary Outcomes

Gastroesophageal Reflux Disease (GERD) symptom elimination
time frame: 6-month follow-up

Secondary Outcomes

Elimination of Proton Pump Inhibitor (PPI) usage
time frame: at 12-, 24- and 36-month follow-up
Esophageal acid exposure
time frame: at 6-, 12-, 24- and 36-month follow-up
Healing of reflux esophagitis
time frame: at 12, 24- and 36-month follow-up
Safety outcomes
time frame: first 30 days
Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination
time frame: at 12-, 24- and 36-month follow-up

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Age 18-75 years - GERD for > 1 year - History of daily PPIs use for > 6 months - Moderate to severe typical or atypical GERD symptoms off PPIs - Complete (responders) or partial (nonresponders) symptom control on PPIs - Deteriorated gastroesophageal junction (Hill grade II or III) - Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow testing - Willingness to undergo pH/impedance testing, if required - Willingness to cooperate with the postoperative diet for 6 weeks - Availability for follow up visits at 6 months and 12 months - Willingly and cognitively signed informed consent Exclusion Criteria: - BMI > 35 - Incompletely reducible hiatal hernia with residual of > 5 mm - Esophagitis grade D - Barrett's Esophagus > 2 cm - Esophageal ulcer - Fixed esophageal stricture or narrowing - Portal hypertension and/or varices - 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 disorder - History of any of the following: resective gastric or esophageal surgery, antireflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis - Pregnancy or plans of pregnancy in the next 12 months - Enrollment in another device or drug study that may confound the results

Additional Information

Official title Prospective Outcome Evaluation of Transoral Incisionless Fundoplication (TIF) for the Treatment of Gastroesophageal Reflux Disease (GERD): The TIF Registry Study
Principal investigator Reginald CW Bell, MD, FACS
Description Primary Effectiveness Endpoint: Typical and atypical GERD symptom elimination (scores ≤ 2 to each question) or clinically significant improvement (≥ 50% reduction in total scores) at 6-month follow-up compared to baseline. Secondary Effectiveness Endpoints: GERD symptom elimination or clinically significant improvement at 12-month follow-up, 24-month follow-up and 36-month follow-up; complete discontinuation of PPIs; normalization of esophageal acid exposure; significant reduction in reflux episodes; healing of reflux esophagitis; reduction of hiatal hernia; safety supported by low incidence of serious adverse events.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by EndoGastric Solutions.