RETHINK REFLUX Registry

Gastroesophageal Reflux Clinical Trial

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

Status Active, not recruiting

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Gastroesophageal Reflux

• NCT number: NCT04253392
• Study type: Observational [Patient Registry]
• Source: Ethicon Endo-Surgery
• Status: Active, not recruiting
• Start date: July 8, 2020
• Completion date: July 31, 2032