Gastroesophageal RefluxNCT04253392
RETHINK REFLUX Registry
An observational study of Gastroesophageal Reflux, run by Ethicon Endo-Surgery at 28 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- LINX Reflux Management System
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 28 sitesin 6 countries
- Study dates
- 8 Jul 2020to 31 Jul 2032
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
28 sites in 6 countries.
28 sites in 6 countries
United States21 sites
Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, 18102
Panhandle Weight Loss Center
Amarillo, Texas, 79106
Fox Valley Surgical Associates
Appleton, Wisconsin, 54911
The Ohio State University
Columbus, Ohio, 43210
Saint Elizabeth Healthcare Edgewood
Edgewood, Kentucky, 41017
Institute of Esophageal and Reflux Surgery
Englewood, Colorado, 80113
East Carolina University / Vidant Medical Center
Greenville, North Carolina, 27834
Minimal Access Surgery/Prisma Health - Upstate
Greenville, South Carolina, 29607
Adv Surg Assoc / Self Regional Healthcare
Greenwood, South Carolina, 29646
Houston Methodist
Houston, Texas, 77030
Gen Surg Assoc / Fairfield Medical Center
Lancaster, Ohio, 43130
Sparrow Hospital / Sparrow Medical Group
Lansing, Michigan, 48912
Keck Hospital of USC
Los Angeles, California, 90033
University of South Alabama
Mobile, Alabama, 36617
OSF Medical Group
Peoria, Illinois, 61615
Richmond Surg / Henrico Doctors' Hospital
Richmond, Virginia, 23229
Bariatric Medical Institute of Texas
San Antonio, Texas, 78258
Swedish Medical Center
Seattle, Washington, 98104
University of Southern Florida (Tampa General Hospital)
Tampa, Florida, 33606
NW Allied Bariatric and Foregut Surgery
Tucson, Arizona, 85741
Lexington Surgery
West Columbia, South Carolina, 29169
United Kingdom3 sites
Epsom Hospital
Epsom, KT18 7EG
Guy's and St. Thomas' Hospitals
London, SE1 7EH
RefluxUK
Royal Tunbridge Wells, TN3 0RD
Italy1 site
Univ of Milano / IRCCS Policlinico San Donato
San Donato Milanese, 20097
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastroesophageal Reflux
- Being tested
- LINX Reflux Management System
- Keywords
- Gastroesophageal Reflux Disease, GERD, Reflux, Regurgitation, Esophageal Disease, Lower Esophageal Sphincter, LES, Magnetic Sphincter Augmentation, MSA
- Medical subject headings
- Gastroesophageal Reflux, Esophageal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LINX Reflux Management SystemDevice
Also called LINX
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Safety - Explant/Removal
LINX explant/removal
Measured: 10 years
Safety - Hiatal Hernia Reoccurrence
Hiatal hernia requiring repair (occurring after the LINX implant)
Measured: 10 years
Secondary outcomes (4)
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:
- Percentage of subjects reporting >or=50% reduction in GERD-HRQL scores
- 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
- Percentage of subjects reporting > or = 50% reduction in average daily proton pump inhibitor (PPI) use
Measured: 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
Measured: 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
Measured: 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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start8 Jul 2020
- Primary completion31 Jul 2032 (estimated)
- Study completion31 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery Lowell, MD, Study director, Ethicon Endo-Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253392
- Sponsor's protocol ID
- TRX_2018_01
- Status last verified
- Sep 2026
- First submitted
- 31 Jan 2020
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research to Further Inform Thinking About the Role of LINX for Reflux Disease
- ClinicalTrials.gov ID
- NCT04253392
- Acronym / sponsor ID
- TRX_2018_01
- Conditions
- Gastroesophageal Reflux
- Keywords
- Gastroesophageal Reflux Disease, GERD, Reflux, Regurgitation, Esophageal Disease, Lower Esophageal Sphincter, LES, Magnetic Sphincter Augmentation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 31 Jul 2032 (estimated)
- Study completion
- 31 Jul 2032 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LINX Reflux Management SystemAlso: LINXThe 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. | Device | – |
Primary outcome
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
Safety - Explant/Removal
Time frame: 10 years
LINX explant/removal
Safety - Hiatal Hernia Reoccurrence
Time frame: 10 years
Hiatal hernia requiring repair (occurring after the LINX implant)
4 secondary outcomes
Effectiveness
Time frame: 10 years
Health Economics - Work Productivity and Activity Impairment
Time frame: 10 years
Health Economics - GERD Treatment Decision-Making Process (Subject's Perspective)
Time frame: Baseline
Health Economics - Healthcare Utilization
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffery Lowell, MD study director
Ethicon Endo-Surgery
28 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux, run by Ethicon Endo-Surgery at 28 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, United Kingdom, Austria, Germany, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Adverse Events (time frame: 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.