For Healthcare Professionals

RETHINK REFLUX Registry

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Subject is >or=21 years old
  2. Subject with prospective plans for a LINX procedure
  3. Subject provides written informed consent
  4. Subject must be willing and able to complete questionnaires/ surveys electronically (ePROs)

EXCLUSION CRITERIA

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.


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Gastroesophageal Reflux

Age (in years)

21 - 99

Participants needed

500

Est. Completion Date

Jul 31, 2032

Treatment type

Observational [Patient Registry]


Sponsor

Ethicon Endo-Surgery

ClinicalTrials.gov identifier

NCT04253392

Study number

TRX_2018_01

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