Loading clinical trials...

A Post-Approval Study of the LINX® Reflux Management System | Clinical Trials | Clareo Health

COMPLETED

A Post-Approval Study of the LINX® Reflux Management System

NCT01940185•Torax Medical Incorporated

Summary

A Post-Approval Study of the LINX® Reflux Management System in a prospective, multicenter, single-arm study, with patients as their own control to monitor the safety and efficacy of the LINX implant procedure and device in a post-approval environment to supplement existing safety and efficacy data.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient is a candidate for treatment with the LINX Reflux Management System
•Patient has provided written informed consent for participation in the post-approval study.
•Patient has indicated a willingness to comply with study requirements and the follow-up schedule and assessments.
•Patient has been diagnosed with GERD as defined by abnormal pH testing.
•Patient continues to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.

Exclusion Criteria

•Patients with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
•Known circumstances that would make it unlikely for the patient to complete follow-up through 60 months.

Locations (19)

Keck Medical Center of Univeristy of Southern California

Los Angeles, California, United States

University of California San Diego

San Diego, California, United States

Swedish Medical Center/SurgOne

Englewood, Colorado, United States

Albany Surgical

Albany, Georgia, United States

Esophageal Institute of Atlanta, PC.

Atlanta, Georgia, United States

Candler Hospital

Savannah, Georgia, United States

Bingham Memorial Hospital

Blackfoot, Idaho, United States

Beth Israel

Boston, Massachusetts, United States

Cuyuna Regional Medical Center

Crosby, Minnesota, United States

VIP Surg PLLC

Las Vegas, Nevada, United States

Key Dates

Start Date

June 30, 2012

Primary Completion Date

June 30, 2023

Completion Date

June 30, 2023

Last Updated

January 5, 2024

Enrollment

200

ACTUAL participants

Conditions

Gastroesophageal Reflux Disease (GERD)

Interventions

LINX device

DEVICE

Evaluation of the Effectiveness of the Ezisurg Stapling (Ezi Endo Lite) During Laparoscopic Nissen Sleeve Gastrectomy

NCT07344935

Gastroesophageal Reflux Disease (GERD)

View study

NOT_YET_RECRUITINGNA

Effect of Breathing Training on Symptoms of Gastroesophageal Reflux Disease

NCT07179250

Incentive SpirometerDiaphragmatic Breathing+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Post-Approval Study of the LINX® Reflux Management System

Inclusion Criteria

Exclusion Criteria

Evaluation of the Effectiveness of the Ezisurg Stapling (Ezi Endo Lite) During Laparoscopic Nissen Sleeve Gastrectomy

Effect of Breathing Training on Symptoms of Gastroesophageal Reflux Disease

Mucosal Impedance in Pediatric Population

Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)

Medigus Ultrasonic Surgical Endostapler (MUSE) Registry

Racial Disparity in Barrett's Esophagus