An observational study in Gastroesophageal Reflux, sponsored by Ethicon Endo-Surgery. Active, not recruiting at 28 sites in 6 countries. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Ethicon Endo-Surgery · Observational
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.
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.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 500 is above the median of 180 across 298 observational studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Ethicon Endo-Surgery is the lead sponsor of 47 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
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)
Exclusion Criteria:
Note: Physicians should refer to the LINX Reflux Management System IFU for a complete list of contraindications, warnings, and precautions.
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.
Also known as: LINX
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
Time frame: 10 years
Safety - Explant/Removal
LINX explant/removal
Time frame: 10 years
Safety - Hiatal Hernia Reoccurrence
Hiatal hernia requiring repair (occurring after the LINX implant)
Time frame: 10 years
Effectiveness
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
Time frame: 10 years
Health Economics - Work Productivity and Activity Impairment
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
Time frame: 10 years
Health Economics - GERD Treatment Decision-Making Process (Subject's Perspective)
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
Time frame: Baseline
Health Economics - Healthcare Utilization
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.
Time frame: 10 years
Plan to share: Yes — 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Ethicon Endo-Surgery