RETHINK REFLUX Registry

March 25, 2024 updated by: Ethicon Endo-Surgery

Research to Further Inform Thinking About the Role of LINX for Reflux Disease

The RETHINK REFLUX Registry is a post-market prospective, multi-center, observation, single arm, long-term safety surveillance registry of subjects implanted with the LINX device. The primary objective of the study is to confirm the long-term safety profile of the LINX device and procedure (implant/explant) up to 10 years post-implant.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The RETHINK REFLUX Registry or Research to further inform thinking about the role of LINX for Reflux Disease is sponsored by Ethicon Endo-Surgery, Inc. This is a post-market prospective, multi-center, observational, single arm, long-term safety surveillance registry of subjects implanted with the LINX device. Up to 500 subjects will be enrolled and implanted at up to 50 centers in both the US and selected countries outside the US with regulatory approval for the LINX Reflux Management System. The study will collect data from patients 10 years post implant. The primary objective of the study is to confirm the long-term safety profile of the LINX device and procedure (implant/explant). Secondary objectives include Effectiveness, Health Economics and Health Utilization.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

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

Study Contact

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • MedUni Wien / Universitatsklinik fur Chirurgie
  • Germany
      • Herne, Germany, 44625
        • Marien hospital Herne
  • Italy
      • San Donato Milanese, Italy, 20097
        • Univ of Milano / IRCCS Policlinico San Donato
  • Singapore
      • Singapore, Singapore, 119228
        • National University Hospital
  • United Kingdom
      • Epsom, United Kingdom, KT18 7EG
        • Epsom Hospital
      • London, United Kingdom, SE1 7EH
        • Guy's and St. Thomas' Hospitals
      • Tunbridge Wells, United Kingdom, TN3 0RD
        • RefluxUK
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36617
        • University of South Alabama
    • Arizona
      • Tucson, Arizona, United States, 85741
        • NW Allied Bariatric and Foregut Surgery
    • California
      • Los Angeles, California, United States, 90033
        • Keck Hospital of USC
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Institute of Esophageal and Reflux Surgery
    • Florida
      • Tampa, Florida, United States, 33606
        • University of Southern Florida (Tampa General Hospital)
    • Illinois
      • Peoria, Illinois, United States, 61615
        • OSF Medical Group
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Saint Elizabeth Healthcare Edgewood
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Sparrow Hospital / Sparrow Medical Group
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • East Carolina University / Vidant Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
      • Lancaster, Ohio, United States, 43130
        • Gen Surg Assoc / Fairfield Medical Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18102
        • Lehigh Valley Hospital - Cedar Crest
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Minimal Access Surgery/Prisma Health - Upstate
      • Greenwood, South Carolina, United States, 29646
        • Adv Surg Assoc / Self Regional Healthcare
      • West Columbia, South Carolina, United States, 29169
        • Lexington Surgery
    • Texas
      • Amarillo, Texas, United States, 79106
        • Panhandle Weight Loss Center
      • Houston, Texas, United States, 77030
        • Houston Methodist
      • San Antonio, Texas, United States, 78258
        • Bariatric Medical Institute of Texas
    • Virginia
      • Richmond, Virginia, United States, 23229
        • Richmond Surg / Henrico Doctors' Hospital
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Fox Valley Surgical Associates

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients successfully implanted (treated) with the LINX Reflux Management System for the treatment of GERD (Implant success defined as leaving the surgical suite with a device in situ)

Description

Inclusion Criteria:

  1. Subject is >or=21 years old
  2. Subject with prospective plans for a LINX procedure
  3. Subject provides written informed consent
  4. Subject must be willing and able to complete questionnaires/ surveys electronically (ePROs)

Exclusion Criteria:

  1. Subject who was previously implanted with LINX device
  2. Any reason which the Principal Investigator believes may cause the subject to be non-compliant with or unable to meet the protocol requirements (i.e. medical illness and/or limited life expectancy of less than 10 years)

Note: Physicians should refer to the LINX Reflux Management System IFU for a complete list of contraindications, warnings, and precautions.

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: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - Adverse Events
Time Frame: 10 years

Adverse events related to the LINX device and/or procedure (implant/explant) limited to:

  • All related serious adverse events
  • All related adverse events of dysphagia and or odynophagia requiring treatment (only)
  • LINX migration
  • LINX erosion
10 years
Safety - Explant/Removal
Time Frame: 10 years
LINX explant/removal
10 years
Safety - Hiatal Hernia Reoccurrence
Time Frame: 10 years
Hiatal hernia requiring repair (occurring after the LINX implant)
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness
Time Frame: 10 years

Follow-up questionnaires Gastroesophageal Reflux Disease Esophageal Health Related Quality of Life Questionnaire (GERD-HRQL), Foregut Symptoms Questionnaire (FSQ) and GERD Medication Survey] will be collected and compared to baseline with evaluation to include:

  1. Percentage of subjects reporting >or=50% reduction in GERD-HRQL scores

  2. Percentage of subjects reporting the following on the FSQ:

    • Elimination of moderate or severe regurgitation
    • Reduction in extra-esophageal symptoms
    • Maintain the ability to belch
    • Maintain the ability to vomit
  3. Percentage of subjects reporting > or = 50% reduction in average daily proton pump inhibitor (PPI) use
10 years
Health Economics - Work Productivity and Activity Impairment
Time Frame: 10 years

Measure of the impact of GERD on a subject's ability to work will be collected through the responses on the Work Productivity and Activity Impairment (WPAI) questionnaire. Percentages of impairment at baseline will be compared to scores collected annually. Four types of scores will be analyzed:

  • Absenteeism (work time missed)
  • Presenteeism (impairment of work/ reduced on-the-job effectiveness)
  • Work productivity loss (overall work impairment/ absenteeism plus presenteeism)
  • Activity impairment
10 years
Health Economics - GERD Treatment Decision-Making Process (Subject's Perspective)
Time Frame: Baseline
To better understand a subject's process for making GERD related healthcare decisions and his/her care pathways, the LINX Interest Survey will be collected once at baseline, prior the implant procedure
Baseline
Health Economics - Healthcare Utilization
Time Frame: 10 years
Analysis of healthcare economics in subjects who seek treatment for worsening of GERD symptoms and device/procedural complications over 10 years. A Healthcare Encounter Survey will be completed by subjects.
10 years

Collaborators and Investigators

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

Sponsor

Ethicon Endo-Surgery

Investigators

  • Study Director: Jörg Tomaszewski, MD, Ethicon Endo-Surgery

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)

July 8, 2020

Primary Completion (Estimated)

July 31, 2032

Study Completion (Estimated)

July 31, 2032

Study Registration Dates

First Submitted

January 31, 2020

First Submitted That Met QC Criteria

January 31, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRX_2018_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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.

Clinical Trials on Gastroesophageal Reflux

Clinical Trials on LINX Reflux Management System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe