LINX Reflux Management System Clinical Study Protocol

Not Applicable

Completed

Conditions: Gastroesophageal Reflux

Interventions: Device: Magnetic Sphincter Augmentation

Registration Number: NCT00776997

Lead Sponsor: Torax Medical Incorporated

Brief Summary: The purpose of the study is to evaluate the safety and effectiveness of the LINX Reflux Management System in the treatment of Gastroesophageal Reflux Disease (GERD).

Detailed Description: At present, the primary alternative for GERD patients with an incomplete symptomatic response to proton-pump inhibitors (PPIs) is laparoscopic Nissen fundoplication. This surgical procedure continues to be the prevalent non-medical treatment option for GERD patients, despite several important limitations. First, it is a very traumatic procedure, requiring portions of the stomach to be dissected and then wrapped around the tubular esophagus, creating permanent anatomic alterations. Secondly, it can create significant side effects, such as gas bloat syndrome, the inability to belch and the inability to vomit.

The intent of the LINX System is to allow a surgeon, using existing laparoscopic techniques and instruments, to augment a weak LES and restore the defective barrier at the gastroesophageal junction (GEJ). This defect of the GEJ is the source of abnormal reflux. The LINX device is an expandable string of individual titanium beads with magnetic cores. The device is laparoscopically placed as a ring around the lower esophageal sphincter. The magnetic attraction of the beads augments the esophageal sphincter's ability to resist gastric pressures that cause reflux. At rest, the LINX device encircles the sphincter with each bead resting against an adjacent bead, to avoid compression of the tubular esophagus. When swallowing, higher pressures are created, allowing the magnetic bond between beads to break, and the LINX implant to expand radially. This serves to preserve swallow and other physiologic functions, such as belching and vomiting, and avoids the side effect of post-prandial bloating. The device can be placed with minimal dissection, preserving anatomy, and is also removable, if necessary. This provides important benefits as it preserves the native anatomy, unlike the Nissen procedure.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

Inclusion Criteria

Subject must be at least 18 years of age and at least the minimum Age of Majority according to applicable State or Country Law and must be less than 75 years of age, with a life expectancy > 3 years
Subject is a suitable surgical candidate, i.e. is able to undergo general anesthesia and laparoscopic surgery
Documented typical symptoms of gastroesophageal reflux disease (GERD) for longer than 6 months (regurgitation or heartburn which is defined as a burning epigastic or substernal pain which responds to acid neutralization or suppression)
Patient 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.
Subjects with symptomatic improvement on proton-pump inhibitor (PPI) therapy demonstrated by a GERD-Health-Related Quality of Life (GERD-HRQL) score of ≤ 10 on proton-pump inhibitors and ≥ 15 off PPIs, or subjects with a ≥ 6 point improvement when comparing their on PPI and off PPI GERD-HRQL score
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

Exclusion Criteria

The procedure is an emergency procedure
Currently being treated with another investigational drug or investigational device
History of gastroesophageal surgery, anti-reflux procedures, or gastroesophageal/gastric cancer
Any previous endoscopic anti-reflux intervention for GERD
Suspected or confirmed esophageal or gastric cancer
Any size hiatal hernia >3cm as determined by endoscopy
Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences
Esophagitis - Grade C or D (LA Classification)
Body Mass Index (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
Subject has history of or known Barrett's esophagus
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
Medical illness (i.e. congestive heart failure) that may cause the subject to be non-compliant with or able to meet the protocol requirements or is associated with limited life expectancy (i.e. less than 3 years)
Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that exhibit depression that are on appropriate medication(s) are allowable.
Suspected or known allergies to titanium, stainless steel, nickel or ferrous materials
Subject has an electrical implant or metallic, abdominal implants

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magnetic Sphincter Augmentation	Magnetic Sphincter Augmentation	Single-arm study: all subjects were treated with magnetic sphincter augmentation. A subject's baseline measurements prior to sphincter augmentation were compared to post-sphincter augmentation measurements. Subjects served as their own control.

Primary Outcome Measures

Name	Time	Method
Rate of Occurrence for Device and Procedure Related Serious Adverse Events (SAEs).	through 24 months	SAE was defined as any untoward medical occurrence, whether related to the study device or procedure or not, that meets one or more of the following criteria: * Results in death * Is life-threatening * Requires subject hospitalization \> 24 hours * Requires prolongation of an existing hospitalization * Results in persistent or significant disability/incapacity * Results in fetal distress, fetal death, or a congenital anomaly or birth defect * Requires intervention to prevent permanent impairment or damage. Outcome measure reports number of subjects with reported events.
Normalization of Esophageal Acid Exposure Time or Reduced Total Acid Exposure Time of at Least 50% Compared to the Subject's Baseline Measurement by Esophageal pH Testing.	12 Months	The analysis cohort for the primary efficacy analysis was the treated population which includes all implanted subjects and was determined through esophageal pH testing.

Secondary Outcome Measures

Name	Time	Method
At Least a 50% Reduction in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Total Score Compared to Baseline	12 months
Average Daily Proton-pump Inhibitor (PPI) Dosage Reduced by at Least 50% Compared to Baseline	12 months

Trial Locations

Locations (14): The Ohio State University Medical Center / Center for Minimally Invasive Surgery
🇺🇸
Columbus, Ohio, United States
University of California - San Diego
🇺🇸
San Diego, California, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Knox Community Hospital
🇺🇸
Mount Vernon, Ohio, United States
Gundersen Lutheran Clinic
🇺🇸
La Crosse, Wisconsin, United States
Washington University - Division of Gastroenterology
🇺🇸
Saint Louis, Missouri, United States
University of Washington Medical Center
🇺🇸
Seattle, Washington, United States
Phoebe Putney Memorial Hospital
🇺🇸
Albany, Georgia, United States
Abbott Northwestern Hospital/MNGI
🇺🇸
Minneapolis, Minnesota, United States
Academic Medical Center
🇳🇱
Amsterdam, Netherlands
Legacy Health System
🇺🇸
Portland, Oregon, United States
USC Keck School of Medicine
🇺🇸
Los Angeles, California, United States
University of Rochester Medical Center
🇺🇸
Rochester, New York, United States
Mayo Clinic
🇺🇸
Jacksonville, Florida, United States