RELIEF Europe Study
NCT02762487 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2017-10-16
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
- Obesity
- LSG
- Laparoscopic Sleeve Gastrectomy
Interventions
- DEVICE
-
The LINX® Reflux Management System
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
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-11-30
- Primary Completion
- 2017-02-28
- Completion
- 2017-02-28
Countries
- Germany
- Italy
Study Locations
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