RELIEF Europe Study

NCT02762487 | Terminated

• 1 other identifier: 4700
• Study Type: interventional
• Target: 7
• Locations: 2 countries
• Sites: 4

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

LINX arm

EXPERIMENTAL

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

Device: The LINX® Reflux Management System

Interventions

The LINX® Reflux Management System 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.

Also known as: LINX device

LINX arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Torax Medical Incorporated: lead

Study Sites (4)

Schön Klinik Nürnberg

Fürth, 90763, Germany

Location

EvK Herne

Herne, 44623, Germany

Location

Uni Klinik Leipzig

Leipzig, Germany

Location

Policlinico San Donato

Milan, 20097, Italy

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Obesity

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 5, 2016
• Study Start: November 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: October 16, 2017

Record last verified: 2017-10

Locations

DE (3); IT (1)