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LINX Reflux Management System in Subjects With GERD Who Have Previously Undergone a Laparoscopic Sleeve Gastrectomy

NCT02429830 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-08-10

Study results available
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Summary

The purpose of this study is to evaluate the LINX device in patients who have previously undergone laparoscopic sleeve gastrectomy (LSG) for obesity and have chronic gastroesophageal reflux disease (GERD). The study will monitor safety and changes in reflux symptoms.

Conditions

  • GERD
  • Gastroesophageal Reflux Disease

Interventions

DEVICE

LINX device

The LINX device is a permanent implant placed at the area of the lower esophageal sphincter (LES) and is designed to augment a weak LES and minimize or eliminate GERD-related symptoms.

Sponsors & Collaborators

  • Torax Medical Incorporated

    lead INDUSTRY

Principal Investigators

  • William J. Petraiuolo, MD · Ethicon Endo-Surgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-05
Primary Completion
2021-06-08
Completion
2021-06-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02429830 on ClinicalTrials.gov