RETHINK REFLUX Registry
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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.
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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