NCT04793035|CompletedResultsDMCFDA Device
Omega Cuff for GERD Feasibility Study
An Observational Clinical Feasibility Study of the Omega Cuff Device for GERD
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Sponsor study identifier
interventional
6
1 country
3
Study Start
August 8, 2023
Actual (reported)Primary Completion
February 13, 2026
Actual (reported)Study Completion
February 13, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 13, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 4, 2021
Actual (reported)March 11, 2021
Actual (reported)August 8, 2023
Actual (reported)February 13, 2026
Actual (reported)February 13, 2026
Actual (reported)September 2, 2026
Actual (reported)Adverse Events
Number of participants who experienced an adverse event
From enrollment to the end of study, up to 24 months
Normalization of pH
Number of participants with normalization of pH (defined as pH \<4 for no more than 4.5% of monitoring time) or a reduction of at least 50% in the total time that pH \<4, at 3 and 12 months relative to baseline.
3 and 12 months post-implant
GERD Health-Related Quality of Life Scale
Number of participants with at least a 50% improvement in the GERD-HRQL scores at 12 months.
12 months post-implant
Single-arm study for enrolled GERD patients to be treated with an Omega-Cuff device
An omega-shaped nitinol device to be placed and secured on the Lower Esophageal Sphincter area
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
HonorHealth
Scottsdale, Arizona, 85258, United States
Keck Medical Center of University of Southern California
Los Angeles, California, 90033, United States
University of Texas at Austin
Austin, Texas, 78712, United States
One limitation of the study is that each surgeon was permitted to use their own method for hernia repair, which could result in inconsistent analyses of the results due to the device used. These inconsistencies could result in subject symptoms such as bloating and dysphagia if the hernia is too tight and could contribute to ongoing GERD symptoms if the hernia isn't tight enough. In the future, it could be beneficial to standardize these processes to minimize variability between surgeons.
6 participants (actual enrollment reported by the registry).
First Submitted
March 4, 2021
First Posted
March 11, 2021
Contact the study team to confirm eligibility.
Study Start
August 8, 2023
Actual (reported)Primary Completion
February 13, 2026
Actual (reported)Study Completion
February 13, 2026
Actual (reported)Last Updated
September 2, 2026
Results First Posted
September 2, 2026
Record last verified: 2026-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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