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

Completed · Not applicable

Conditions studied: GERD, Gastroesophageal Reflux Disease

In brief

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.

Key facts

Study ID

NCT02429830

Run by

Torax Medical Incorporated

People needed

30

Starts

2017-04-05

Expected to finish

2021-06-08

Last updated by the study team

2022-08-10

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects included in the study must meet all the following criteria:
• Age >22 years
• Laparoscopic sleeve gastrectomy (LSG) for obesity >12 months prior to proposed device implantation date.
• Subject is a surgical candidate, i.e. is able to undergo general anesthesia and laparoscopic surgery.
• Documented typical symptoms of GERD for longer than 6 months (regurgitation or heartburn which is defined as a burning epigastric or substernal pain which responds to acid neutralization or suppression).
• Subject requires daily proton pump inhibitor or other anti-reflux drug therapy.
• Total distal ambulatory esophageal pH must meet the following criteria: pH <4 for >4.5% of the time. Note: Subjects shall have discontinued any GERD medications for at least 7 days prior to testing, with the exception of antacids up to the morning of testing.
• Subjects with symptomatic improvement on PPI therapy demonstrated by a GERD-HRQL score of <10 on PPI and >15 off PPI, or subjects with a >6 point improvement when comparing their on PPI and off PPI GERD-HRQL scores.
• GERD symptoms, in absence of PPI therapy (minimum 7 days).
• If the subject is of child bearing potential must have a negative pregnancy test within one week prior to implant and must agree to use effective means of birth control during the course of the study.
• Subject is willing and able to cooperate with follow-up examinations
• Subject has been informed of the study procedures and the treatment and has signed an informed consent form.

You may not qualify if…

• Subjects should be excluded from the study based on the following criteria:
• The procedure is an emergency procedure.
• Suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
• 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 (if using Conventional Manometry). -or- If using High Resolution Manometry (exclude for any of the following):
• Distal Contractile Integral (DCI) ≤ 450 mmHg·s·cm or
• ≥ 50% ineffective swallows or
• ≥ 50% fragmented swallows (Fragmented swallows are defined as those with a ≥ 5cm break [large] in peristaltic integrity).
• 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.
• Subject has a history of or known esophageal stricture or gross esophageal anatomic abnormalities (Schatzki's ring, obstructive lesions, etc.)
• Subject has esophageal or gastric varices
• History of/or known Barrett's esophagus. Note: The diagnosis of Barrett's esophagus requires both endoscopic and histologic evidence of metaplastic columnar epithelium. Endoscopically, there must be columnar epithelium within the esophagus. Histologically, the epithelium must be metaplastic, as defined by the presence of goblet cells.by
• Subject 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.
• Subject has an electrical implant or metallic, abdominal implants.

Where it is running

• Northwest Allied Bariatric & Foregut Surgery — Tucson, Arizona, United States
• Mercy Health Northwest Arkansas — Rogers, Arkansas, United States
• Keck Medical Center of USC — Los Angeles, California, United States
• Institute of Esophageal and Reflux Surgery — Englewood, Colorado, United States
• RWJBH Univ. Hospital Somerset/Advanced Surgical and Bariatrics of NJ, PA — Somerset, New Jersey, United States
• Buffalo General Medical Center — Buffalo, New York, United States
• Adirondack Surgical Group — Saranac Lake, New York, United States
• East Carolina University — Greenville, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Coastal Carolina Bariatric & Surgical Center — Summerville, South Carolina, United States
• Panhandle Weight Loss Center — Amarillo, Texas, United States
• Gunderson Health System — La Crosse, Wisconsin, United States

Full record on ClinicalTrials.gov

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