Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04253392). StuddyBuddy aggregates publicly available trial information.