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NCT04793035 · ClinicalTrials.gov registry record · NA
Omega Cuff for GERD Feasibility Study
A NA study of GERD, Acid Reflux, Treatment, sponsored by Aplos Medical.
- Active
- Registry status
- NA
- Development phase
- 8
- Enrollment target
- 3
- Study locations
NCT04793035 is a NA study of GERD, Acid Reflux, Treatment that is active but no longer recruiting, run by Aplos Medical. The registered enrollment target is 8 participants. The trial reports 3 study locations across 3 states.
The verdict
NCT04793035, a NA study of GERD, Acid Reflux, Treatment, is active but no longer recruiting, sponsored by Aplos Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
- 3
- Study locations
Study Summary
This clinical feasibility study is to evaluate the performance of the Omega-Cuff in the treatment of acid reflux for up to 15 patients with a 1-year follow-up period. The Omega-shaped nitinol device is placed on top of the esophageal sphincter muscle just above the stomach in a laparoscopic surgical procedure without altering anatomy. In animal studies, the device safely increased the pressure on the sphincter, meaning it increased resistance to acid reflux, but did not interfere with normal food swallowing, meaning food went down to the stomach normally and smoothly. The device is intended to augment the function of the weak sphincter in minimizing acid reflux but allows easy swallowing of food in GERD patients. The clinical feasibility study is to see how well this device functions in patients and to assess its safety profile. This is a permanent implant that will last the lifetime of the patient. The device will not interfere with patients who may need diagnostic MRI scans. The device can be safely removed if needed.
Conditions Studied
Interventions
- DEVICE Omega-Cuff
Study Locations (3)
Arizona
- HonorHealth - Scottsdale
California
- Keck Medical Center of University of Southern California - Los Angeles
Texas
- University of Texas at Austin - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2023-08-08 |
| Est. Completion | 2026-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04793035
The ClinicalTrials.gov registry entry for NCT04793035 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aplos Medical, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with GERD, Acid Reflux, Treatment appearing as the primary indexed condition, and to 1 intervention - of which Omega-Cuff is the first listed.
NCT04793035 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Arizona, California, Texas.
Frequently Asked Questions
What is clinical trial NCT04793035 about?
NCT04793035 is a clinical study titled "Omega Cuff for GERD Feasibility Study". This clinical feasibility study is to evaluate the performance of the Omega-Cuff in the treatment of acid reflux for up to 15 patients with a 1-year follow-up period. The Omega-shaped nitinol device is placed on top of the esophageal sphincter muscle just above the stomach in a laparoscopic surgical...
What is the current status of trial NCT04793035?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 8 participants. The study started on 2023-08-08. Estimated completion is 2026-03-31.
What conditions does trial NCT04793035 study?
This clinical trial studies the following conditions: GERD, Acid Reflux, Treatment.
What interventions are being tested in trial NCT04793035?
The interventions under investigation include: Omega-Cuff (DEVICE).
Who is sponsoring clinical trial NCT04793035?
This trial is sponsored by Aplos Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04793035 being conducted?
This trial has 3 study locations across Arizona, California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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