RELIEF Europe Study

RELIEF Europe Study. A Prospective, Multicenter Study of RefluxManagement With the LINX® System for Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Gastroesophageal Reflux Disease; GERD; Laparoscopic Sleeve Gastrectomy; LSG
• Intervention / Treatment: Device: The LINX® Reflux Management System

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Fürth, Germany, 90763
    • Schön Klinik Nürnberg
  • Herne, Germany, 44623
    • EVK Herne
  • Leipzig, Germany
    • Uni Klinik Leipzig
• Italy
  • Milan, Italy, 20097
    • Policlinico San Donato

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Laparoscopic sleeve gastrectomy (LSG) for obesity >12 months prior to proposed device implantation date.
• Patient is a surgical candidate, i.e. is able to undergo general anesthesia and laparoscopic surgery.
• Documented pathologic esophageal acid exposure by pH monitoring per institution's standard of care (i.e. total distal ambulatory esophageal pH< 4 for ≥ 5.3% (BRAVO) or ≥4.5% (transnasal) or abnormal DeMeester Score (>14.72) within 12 months of proposed implantation date (After Sleeve Gastrectomy).

NOTE: SUBJECTS SHALL HAVE DISCONTINUED ALL GERD MEDICATIONS FOR AT LEAST 7 DAYS PRIOR TO TESTING WITH THE EXCEPTION OF ANTACIDS, WHICH MAY BE TAKEN UP UNTIL THE MORNING OF THE VISIT.

• Chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.
• Age ≥ 21 years
• At least 30% loss of excess weight from date of original LSG surgery.
• Patient is willing and able to cooperate with follow-up examinations.
• Patient has been informed of the study procedures and the treatment and has signed an informed consent form.

Exclusion Criteria:

• Suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
• Prior surgery in the area of the gastroesophageal junction (GEJ), including prior hiatal hernia repair.
• Presence of ˃3 cm hiatal hernia as determined by endoscopy or barium esophagram.
• Subject had any major complications related to the laparoscopic sleeve gastrectomy that may interfere with, or increase the risks of the LINX procedure (such as, but not limited to, leaks from the gastric remnant and infection at the sleeve gastrectomy).
• Plans to surgically revise the gastric pouch (either known preoperatively or decided intraoperatively).
• Currently being treated with another investigational drug or investigational device.
• Suspected or confirmed esophageal or gastric cancer or prior gastric or esophageal surgery or endoscopic intervention for GERD (with the exception of sleeve gastrectomy).
• Distal amplitude <35 mmHg or <70% peristaltic sequences.
• Presence of esophagitis - Grade C or D (LA Classification). BMI >35.
• Symptoms of dysphagia more than once per week within the last 3 months.
• Diagnosed with Scleroderma.
• Diagnosed with an esophageal motility disorder such as but not limited to achalasia, nutcracker esophagus, or diffuse esophageal spasm or hypertensive LES.
• Patient has a history of or known esophageal stricture or gross esophageal anatomic abnormalities (Schatzki's ring, obstructive lesions, etc.).
• Patient has esophageal or gastric varices.
• Patient has Barrett's esophagus.
• Patient cannot understand trial requirements or is unable to comply with follow-up schedule.
• Pregnant or nursing, or plans to become pregnant during the course of the study.
• Any reason which the Investigator believes may cause the subject to be non-compliant with or unable to meet the protocol requirements.
• Patient has an electrical implant or metallic, abdominal implants.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LINX arm; Previous LSG patient will be treated with the LINX device and serve as their own control	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.; Other Names: LINX device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change is GERD-HRQL Score as a measure of efficacy	Baseline, 6 month visit
Number of participants with serious complications as a measure of safety.	6 month visit
Change is total distal acid exposure as a measure of efficacy.	Baseline, 6 month visit

Collaborators and Investigators

• Sponsor: Torax Medical Incorporated

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: May 4, 2016
• First Posted (Estimate): May 5, 2016

Study Record Updates

• Last Update Posted (Actual): October 16, 2017
• Last Update Submitted That Met QC Criteria: October 13, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: 4700