RETHINK REFLUX Registry

Running, not enrolling

Conditions studied: Gastroesophageal Reflux

In brief

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.

Key facts

Study ID

NCT04253392

Run by

Ethicon Endo-Surgery

People needed

500

Starts

2020-07-08

Expected to finish

2032-07-31

Last updated by the study team

2026-07-06

Who can join

Age: 21 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• NW Allied Bariatric and Foregut Surgery — Tucson, Arizona, United States
• Keck Hospital of USC — Los Angeles, California, United States
• Institute of Esophageal and Reflux Surgery — Englewood, Colorado, United States
• University of Southern Florida (Tampa General Hospital) — Tampa, Florida, United States
• OSF Medical Group — Peoria, Illinois, United States
• Saint Elizabeth Healthcare Edgewood — Edgewood, Kentucky, United States
• Sparrow Hospital / Sparrow Medical Group — Lansing, Michigan, United States
• East Carolina University / Vidant Medical Center — Greenville, North Carolina, United States
• The Ohio State University — Columbus, Ohio, United States
• Gen Surg Assoc / Fairfield Medical Center — Lancaster, Ohio, United States
• Lehigh Valley Hospital - Cedar Crest — Allentown, Pennsylvania, United States
• Minimal Access Surgery/Prisma Health - Upstate — Greenville, South Carolina, United States
• Adv Surg Assoc / Self Regional Healthcare — Greenwood, South Carolina, United States
• Lexington Surgery — West Columbia, South Carolina, United States
• Panhandle Weight Loss Center — Amarillo, Texas, United States
• Houston Methodist — Houston, Texas, United States
• Bariatric Medical Institute of Texas — San Antonio, Texas, United States
• Richmond Surg / Henrico Doctors' Hospital — Richmond, Virginia, United States
• Swedish Medical Center — Seattle, Washington, United States
• Fox Valley Surgical Associates — Appleton, Wisconsin, United States
• MedUni Wien / Universitatsklinik fur Chirurgie — Vienna, Austria
• Marien Hospital Herne — Herne, Germany
• Univ of Milano / IRCCS Policlinico San Donato — San Donato Milanese, Italy
• National University Hospital — Singapore, Singapore

Full record on ClinicalTrials.gov

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