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ACTIVE NOT RECRUITING
NCT04793035
NA

Omega Cuff for GERD Feasibility Study

Sponsor: Aplos Medical

View on ClinicalTrials.gov

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.

Official title: An Observational Clinical Feasibility Study of the Omega Cuff Device for GERD

Key Details

Gender

All

Age Range

22 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2023-08-08

Completion Date

2026-03-31

Last Updated

2025-09-10

Healthy Volunteers

No

Interventions

DEVICE

Omega-Cuff

An omega-shaped nitinol device to be placed and secured on the Lower Esophageal Sphincter area

Locations (3)

HonorHealth

Scottsdale, Arizona, United States

Keck Medical Center of University of Southern California

Los Angeles, California, United States

University of Texas at Austin

Austin, Texas, United States