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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: Active study of Gastroesophageal Reflux, sponsored by Ethicon Endo-Surgery.
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, below the 2,871-participant average among 33 other Gastroesophageal Reflux trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Adverse events related to the LINX device and/or procedure (implant/explant) limited to: * All related serious adverse events * All related adverse events of dysphagia and or odynophagia requiring treatment (only) * LINX migration * LINX erosion
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 |
What the registry record for NCT04253392 still lists
NCT04253392 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 2,871-participant average among 33 other Gastroesophageal Reflux trials with a reported enrollment target (83% lower).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
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Where NCT04253392's enrollment target sits among peer trials
500 4th of 33 higher than 30 of 33 other Gastroesophageal Reflux trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroesophageal Reflux trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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