CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Magnetic Sphincter Augmentationdevice
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/NCT00776997
NCT00776997N/ACompleted
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LINX Reflux Management System Clinical Study Protocol

Torax Medical Incorporated·interventional·Posted Oct 22, 2008·Updated May 4, 2018

In Brief

A clinical study evaluating Magnetic Sphincter Augmentation for Gastroesophageal Reflux. Completed, enrolled 100 participants across 14 sites in 2 countries.

Detailed Summary

The purpose of the study is to evaluate the safety and effectiveness of the LINX Reflux Management System in the treatment of Gastroesophageal Reflux Disease (GERD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux
CountriesNetherlands, United States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 22, 2008
Enrollment StartNov 1, 2008
Primary CompletionDec 1, 2010
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 17.7 years ago

Interventions

Magnetic Sphincter Augmentationdevice

The area of the lower esophageal sphincter (LES) is accessed using a standard laparoscopic approach. The tubular esophagus, in the area of the LES, is sized and the appropriately sized sphincter augmentation device is placed circumferentially around the esophagus in the area of the LES. After confirming proper placement, the ends of the device are secured. At this point, the implant procedure is complete, laparoscopic instruments are withdrawn and access points are closed.