Omega Cuff for GERD Feasibility Study
Public ClinicalTrials.gov record NCT04793035. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Observational Clinical Feasibility Study of the Omega Cuff Device for GERD
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04793035
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 6 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 22 Years to 74 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 7, 2023
- Primary completion
- Feb 12, 2026
- Completion
- Feb 12, 2026
- Last update posted
- Sep 1, 2026
2023 – 2026
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HonorHealth | Scottsdale | Arizona | 85258 | — |
| Keck Medical Center of University of Southern California | Los Angeles | California | 90033 | — |
| University of Texas at Austin | Austin | Texas | 78712 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04793035, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 1, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04793035 live on ClinicalTrials.gov.