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NCT04253392 · ClinicalTrials.gov registry record
RETHINK REFLUX Registry
A clinical trial of Gastroesophageal Reflux, sponsored by Ethicon Endo-Surgery.
- Active
- Registry status
- 500
- Enrollment target
- 20
- Study locations
NCT04253392 is a study of Gastroesophageal Reflux that is active but no longer recruiting, run by Ethicon Endo-Surgery. The registered enrollment target is 500 participants, above the 165-participant average among 25 other Gastroesophageal Reflux trials with a reported enrollment target (203% higher). The trial reports 20 study locations across 15 states.
The verdict
NCT04253392, a study of Gastroesophageal Reflux, is active but no longer recruiting, sponsored by Ethicon Endo-Surgery.
- ACTIVE NOT RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DEVICE LINX Reflux Management System
Study Locations (20)
South Carolina
- Minimal Access Surgery/Prisma Health - Upstate - Greenville
- Adv Surg Assoc / Self Regional Healthcare - Greenwood
- Lexington Surgery - West Columbia
Texas
- Panhandle Weight Loss Center - Amarillo
- Houston Methodist - Houston
- Bariatric Medical Institute of Texas - San Antonio
Ohio
- The Ohio State University - Columbus
- Gen Surg Assoc / Fairfield Medical Center - Lancaster
Alabama
- University of South Alabama - Mobile
Arizona
- NW Allied Bariatric and Foregut Surgery - Tucson
California
- Keck Hospital of USC - Los Angeles
Colorado
- Institute of Esophageal and Reflux Surgery - Englewood
Florida
- University of Southern Florida (Tampa General Hospital) - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2020-07-08 |
| Est. Completion | 2032-07-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04253392
The ClinicalTrials.gov registry entry for NCT04253392 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 165-participant average among 25 other Gastroesophageal Reflux trials with a reported enrollment target (203% higher). The listed sponsor is Ethicon Endo-Surgery, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Gastroesophageal Reflux appearing as the primary indexed condition, and to 1 intervention - of which LINX Reflux Management System is the first listed.
NCT04253392 reports 20 study locations spanning 15 distinct geographic areas - top geographies include South Carolina, Texas, Ohio.
Frequently Asked Questions
What is clinical trial NCT04253392 about?
NCT04253392 is a clinical study titled "RETHINK REFLUX Registry". 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/...
What is the current status of trial NCT04253392?
This trial is currently active not recruiting. The enrollment target is 500 participants. The study started on 2020-07-08. Estimated completion is 2032-07-31.
What conditions does trial NCT04253392 study?
This clinical trial studies the following conditions: Gastroesophageal Reflux.
What interventions are being tested in trial NCT04253392?
The interventions under investigation include: LINX Reflux Management System (DEVICE).
Who is sponsoring clinical trial NCT04253392?
This trial is sponsored by Ethicon Endo-Surgery, which has 39 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04253392 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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