NCT04253392

RETHINK REFLUX Registry

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Ethicon Endo-Surgery · Industry
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	LINX Reflux Management System	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.

Timeline

• Start date: 2020-07-08
• Primary completion: 2032-07-31
• Completion: 2032-07-31
• First posted: 2020-02-05
• Last updated: 2026-04-13

Locations

28 sites across 6 countries: United States, Austria, Germany, Italy, Singapore, United Kingdom

Regulatory

• FDA-regulated device study