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

January 2, 2024 updated by: Torax Medical Incorporated
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Keck Medical Center of Univeristy of Southern California
      • San Diego, California, United States, 92103
        • University of California San Diego
    • Colorado
      • Englewood, Colorado, United States, 80110
        • Swedish Medical Center/SurgOne
    • Georgia
      • Albany, Georgia, United States, 31701
        • Albany Surgical
      • Atlanta, Georgia, United States, 30309
        • Esophageal Institute of Atlanta, PC.
      • Savannah, Georgia, United States, 31406
        • Candler Hospital
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Bingham Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel
    • Minnesota
      • Crosby, Minnesota, United States, 56441
        • Cuyuna Regional Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • VIP Surg PLLC
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center - Geauga
      • Columbus, Ohio, United States, 43210
        • Ohio State University Wexner Medical Center
      • Mount Vernon, Ohio, United States, 43050
        • Knox Community Hospital
    • Oregon
      • Portland, Oregon, United States, 97213
        • The Oregon Clinic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Allegheny Western Pennsylvania Hospital
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Virginia Hospital Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert and Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximum medical therapy for the treatment of reflux

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LINX device
Patients implanted with the LINX® Reflux Management System.
Device: LINX device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of total GERD-HRQL score
Time Frame: 6 months, 12 months, and annually to 60 months
Successful reduction of ≥ 50% in the total GERD-HRQL as compared to baseline.
6 months, 12 months, and annually to 60 months
Serious, device-related adverse events
Time Frame: 60 months
Reporting all serious device-related adverse events and summarizing by the number of events, the number of study patients with event, and the percent of study patients implanted with event. No formal statistical hypothesis tests will be conducted.
60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Related Adverse Events
Time Frame: 120 months
Incidence rate of of device- and/or procedure-related adverse events
120 months
pH Measurements
Time Frame: The secondary measurements will be evaluated at yearly interval to 120 months (esophageal pH not conducted at 72, 84, 96 and 108 months)
Reduction from baseline in Total % time esophageal pH<4
The secondary measurements will be evaluated at yearly interval to 120 months (esophageal pH not conducted at 72, 84, 96 and 108 months)
Reduction of Symptoms
Time Frame: The secondary measurements will be evaluated at yearly interval to 120 months
Reduction from baseline on Foregut Symptom Questionnaire (frequency and severity of heartburn and regurgitation, extra-esophageal symptoms and side effect profile). No formal statistical hypothesis tests will be conducted. Any statistical analyses will be primarily descriptive.
The secondary measurements will be evaluated at yearly interval to 120 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Torax Medical Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2012

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

September 6, 2013

First Submitted That Met QC Criteria

September 6, 2013

First Posted (Estimated)

September 12, 2013

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3545

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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