Active — Not RecruitingNot Applicable

RETHINK REFLUX Registry

United States500 participantsStarted 2020-07-08

Plain-language 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.

Who can participate

Age range21 Years – 99 Years

SexALL

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Inclusion criteria

✓. 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)

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)

What they're measuring

Safety - Adverse Events

Timeframe: 10 years

Safety - Explant/Removal

Timeframe: 10 years

Safety - Hiatal Hernia Reoccurrence

Timeframe: 10 years

Trial details

NCT IDNCT04253392

SponsorEthicon Endo-Surgery

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2032-07-31

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