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Active Not Recruiting
NCT04253392
RETHINK REFLUX Registry
Conditions: Gastroesophageal Reflux
Sex: All
Ages: 21 Years – 99 Years
Healthy volunteers: No
Enrollment: 500
Sponsor: Ethicon Endo-Surgery
Location: University of South Alabama Mobile Alabama
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.
Eligibility 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:
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.
Source: ClinicalTrials.gov (NCT04253392). StuddyBuddy aggregates publicly available trial information.