RELIEF Europe Study

NCT ID: NCT02762487

Last Updated: 2017-10-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-02-28

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LINX arm

Previous LSG patient will be treated with the LINX device and serve as their own control

Group Type: EXPERIMENTAL

The LINX® Reflux Management System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

LINX device

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Torax Medical Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Schön Klinik Nürnberg

Fürth, , Germany

EvK Herne

Herne, , Germany

Uni Klinik Leipzig

Leipzig, , Germany

Policlinico San Donato

Milan, , Italy

Countries

Germany; Italy

Other Identifiers

4700

Identifier Type: -

Identifier Source: org_study_id