LINX Reflux Management System Clinical Study Protocol

NCT00776997 | Completed Results

• 1 other identifier: 1802
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 14

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).

Conditions

Gastroesophageal Reflux

Keywords

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (2)

• Rate of Occurrence for Device and Procedure Related Serious Adverse Events (SAEs).

  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.

  through 24 months

• 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.

  The analysis cohort for the primary efficacy analysis was the treated population which includes all implanted subjects and was determined through esophageal pH testing.

  12 Months

Secondary Outcomes (2)

• 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

Study Arms (1)

Magnetic Sphincter Augmentation

OTHER

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.

Device: Magnetic Sphincter Augmentation

Interventions

Magnetic Sphincter Augmentation DEVICE

The area of the lower esophageal sphincter (LES) is accessed using a standard laparoscopic approach. The tubular esophagus, in the area of the LES, is sized and the appropriately sized sphincter augmentation device is placed circumferentially around the esophagus in the area of the LES. After confirming proper placement, the ends of the device are secured. At this point, the implant procedure is complete, laparoscopic instruments are withdrawn and access points are closed.

Also known as: LINX Reflux Management System, Magnetic Esophageal Sphincter

Magnetic Sphincter Augmentation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Torax Medical Incorporated: lead

Study Sites (14)

USC Keck School of Medicine

Los Angeles, California, 90033, United States

Location

University of California - San Diego

San Diego, California, 92103, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Phoebe Putney Memorial Hospital

Albany, Georgia, 31701, United States

Location

Abbott Northwestern Hospital/MNGI

Minneapolis, Minnesota, 55407, United States

Location

Washington University - Division of Gastroenterology

St Louis, Missouri, 63110, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

The Ohio State University Medical Center / Center for Minimally Invasive Surgery

Columbus, Ohio, 43210, United States

Location

Knox Community Hospital

Mount Vernon, Ohio, 43050, United States

Location

Legacy Health System

Portland, Oregon, 97210, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Gundersen Lutheran Clinic

La Crosse, Wisconsin, 54601, United States

Location

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

Related Publications (2)

• Ganz RA, Edmundowicz SA, Taiganides PA, Lipham JC, Smith CD, DeVault KR, Horgan S, Jacobsen G, Luketich JD, Smith CC, Schlack-Haerer SC, Kothari SN, Dunst CM, Watson TJ, Peters J, Oelschlager BK, Perry KA, Melvin S, Bemelman WA, Smout AJ, Dunn D. Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. Clin Gastroenterol Hepatol. 2016 May;14(5):671-7. doi: 10.1016/j.cgh.2015.05.028. Epub 2015 Jun 2.

  PMID: 26044316 DERIVED

• Ganz RA, Peters JH, Horgan S, Bemelman WA, Dunst CM, Edmundowicz SA, Lipham JC, Luketich JD, Melvin WS, Oelschlager BK, Schlack-Haerer SC, Smith CD, Smith CC, Dunn D, Taiganides PA. Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med. 2013 Feb 21;368(8):719-27. doi: 10.1056/NEJMoa1205544.

  PMID: 23425164 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Amy Derosier, VP of Clinical Affairs
• Organization: Torax Medical

aderosier@toraxmedical.com

651-361-8900

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: October 20, 2008
• First Posted: October 22, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: September 1, 2011
• Last Updated: May 4, 2018
• Results First Posted: November 13, 2013

Record last verified: 2018-03

Locations

NL (1); US (13)