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RETHINK REFLUX Registry

RETHINK REFLUX Registry

Recruiting
21-99 years
All
Phase N/A

Overview

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.

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, observation, 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.

Eligibility

Inclusion Criteria:

  1. Subject is >or=21 years old
  2. Subject must be a candidate for the LINX Reflux Management System as defined by the Instructions for use (IFU) with plans for a LINX procedure
  3. Subject provides written informed consent
  4. Subject must be willing and able to complete questionnaires/ surveys electronically (ePROs)

Additional Inclusion Criteria (for Sub-Study/ Hugo only)

5. Subject must be willing and able to use the Hugo application to share personal health records (PHR) information

Exclusion Criteria:

  1. Subject who was previously implanted with LINX device
  2. 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.

Study details
    Gastroesophageal Reflux

NCT04253392

Ethicon Endo-Surgery

16 February 2024

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