RETHINK REFLUX Registry
Research to Further Inform Thinking About the Role of LINX for Reflux Disease
1 other identifier
observational
500
6 countries
28
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Longer than P75 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
July 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2032
April 13, 2026
April 1, 2026
12.1 years
January 31, 2020
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Safety - Adverse Events
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
LINX explant/removal
10 years
Safety - Hiatal Hernia Reoccurrence
Hiatal hernia requiring repair (occurring after the LINX implant)
10 years
Secondary Outcomes (4)
Effectiveness
10 years
Health Economics - Work Productivity and Activity Impairment
10 years
Health Economics - GERD Treatment Decision-Making Process (Subject's Perspective)
Baseline
Health Economics - Healthcare Utilization
10 years
Interventions
The LINX Reflux Management System consists of a series of titanium beads each with a magnetic core connected with independent titanium wires to form an annular shape when implanted. The attractive force of the magnetic beads is designed to provide additional strength to keep a weak lower esophageal sphincter (LES) closed. During swallowing, the magnetic beads slide away from each other on the independent titanium wire "links" to allow esophageal distention as the bolus passes by.
Eligibility Criteria
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)
You may qualify if:
- Subject is \>or=21 years old
- Subject with prospective plans for a LINX procedure
- Subject provides written informed consent
- Subject must be willing and able to complete questionnaires/ surveys electronically (ePROs)
You may not qualify if:
- Subject who was previously implanted with LINX device
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
University of South Alabama
Mobile, Alabama, 36617, United States
NW Allied Bariatric and Foregut Surgery
Tucson, Arizona, 85741, United States
Keck Hospital of USC
Los Angeles, California, 90033, United States
Institute of Esophageal and Reflux Surgery
Englewood, Colorado, 80113, United States
University of Southern Florida (Tampa General Hospital)
Tampa, Florida, 33606, United States
OSF Medical Group
Peoria, Illinois, 61615, United States
Saint Elizabeth Healthcare Edgewood
Edgewood, Kentucky, 41017, United States
Sparrow Hospital / Sparrow Medical Group
Lansing, Michigan, 48912, United States
East Carolina University / Vidant Medical Center
Greenville, North Carolina, 27834, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Gen Surg Assoc / Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, 18102, United States
Minimal Access Surgery/Prisma Health - Upstate
Greenville, South Carolina, 29607, United States
Adv Surg Assoc / Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
Lexington Surgery
West Columbia, South Carolina, 29169, United States
Panhandle Weight Loss Center
Amarillo, Texas, 79106, United States
Houston Methodist
Houston, Texas, 77030, United States
Bariatric Medical Institute of Texas
San Antonio, Texas, 78258, United States
Richmond Surg / Henrico Doctors' Hospital
Richmond, Virginia, 23229, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Fox Valley Surgical Associates
Appleton, Wisconsin, 54911, United States
MedUni Wien / Universitatsklinik fur Chirurgie
Vienna, 1090, Austria
Marien Hospital Herne
Herne, 44625, Germany
Univ of Milano / IRCCS Policlinico San Donato
San Donato Milanese, 20097, Italy
National University Hospital
Singapore, 119228, Singapore
Epsom Hospital
Epsom, KT18 7EG, United Kingdom
Guy's and St. Thomas' Hospitals
London, SE1 7EH, United Kingdom
RefluxUK
Royal Tunbridge Wells, TN3 0RD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jörg Tomaszewski, MD
Ethicon Endo-Surgery
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2020
First Posted
February 5, 2020
Study Start
July 8, 2020
Primary Completion (Estimated)
July 31, 2032
Study Completion (Estimated)
July 31, 2032
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.