RETHINK REFLUX Registry

  • STATUS
    Recruiting
  • End date
    Jul 31, 2032
  • participants needed
    500
  • sponsor
    Ethicon Endo-Surgery
Updated on 19 February 2024
reflux
linx procedure

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.

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.

Details
Condition Gastroesophageal Reflux
Age 21years - 99years
Treatment LINX Reflux Management System
Clinical Study IdentifierNCT04253392
SponsorEthicon Endo-Surgery
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is >or=21 years old
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
Subject provides written informed consent
Subject must be willing and able to complete questionnaires/ surveys electronically (ePROs)
Additional Inclusion Criteria (for Sub-Study/ Hugo only)
\. Subject must be willing and able to use the Hugo application to share
personal health records (PHR) information

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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