CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 65 enrolled
Drug / intervention
PPI +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01647958
NCT01647958N/ACompleted
CompareCT.gov

Transoral Incisionless Fundoplication (TIF) Versus Medical Proton Pump Inhibitor (PPI) Management of Refractory Gastroesophageal Reflux Disease (GERD) Symptoms

EndoGastric Solutions·interventional·Posted Jul 24, 2012·Updated Nov 23, 2020

In Brief

A clinical study evaluating EsophyX System with SerosaFuse fasteners and PPI for Gastroesophageal Reflux Disease (GERD). Completed, enrolled 65 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the efficacy and safety of Transoral Incisionless Fundoplication (TIF) performed with EsophyX as compared to proton pump inhibitor (PPI) therapy for the treatment of chronic Gastroesophageal Reflux Disease (GERD) patients with refractory symptoms on Proton Pump Inhibitors (PPIs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux Disease (GERD)
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 24, 2012
Enrollment StartJun 1, 2012
Primary CompletionOct 1, 2015
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 13.9 years ago

Interventions

EsophyX System with SerosaFuse fastenersdevice

Transoral Incisionless Fundoplication (TIF)/Transoral incisionless esophago-gastric fundoplication using the EsophyX System with SerosaFuse fasteners

PPIdrug

Control Arm participants will take maximum standard dose of PPI during Initial Study period