Omega Cuff for GERD Feasibility Study

NCT04793035 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 03-0001-000
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief 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

GERD, Acid Reflux, Treatment

Outcome Measures

Primary Outcomes (5)

• Outcome 1

  The primary safety parameter will be a summary at 12 months of the rate of all adverse events at various time points post-implant procedure. This will be compared to other GERD treatment results.

  12 months

• Outcome 2

  The primary effectiveness endpoint of this study is the pH measurements result. Efficacy here is defined as the amount of time the pH\<4 is 4.5% of the time or less, or the amount of time with pH\<4 is at least 50% less than the baseline measurement.

  12 months

• Outcome 3

  The primary quality of life endpoint will be at least a 50% improvement in the GERD-HRQL scores at 12 months.

  12 months

• Outcome 4

  Reduction of PPI usage. The reduction of daily PPI use by subjective assessment using the GERD-HRQL.

  12 mohths

• Outcome 5

  LES function. The LES function will be characterized by objective measurements using a 24hr pH profile, manometry/motility, endoscopy, and barium esophagram.

  12 months

Study Arms (1)

Enrolled patients

EXPERIMENTAL

Single-arm study for enrolled GERD patients to be treated with an Omega-Cuff device

Device: Omega-Cuff

Interventions

Omega-Cuff DEVICE

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

Enrolled patients

Eligibility Criteria

• Age: 22 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 22 years of age and must be less than 75 years of age with a life expectancy \> 3 years.
• Subject is a suitable surgical candidate, i.e., is able to undergo general anesthesia and laparoscopic surgery.
• Subject has documented typical symptoms of gastroesophageal reflux disease (GERD) for longer than 6 months (regurgitation or heartburn that is defined as a burning epigastric or substernal pain that responds to acid neutralization or suppression).
• Subject requires daily proton pump inhibitor or other anti-reflux drug therapy.
• Total Distal Ambulatory Esophageal pH must meet the following criteria: pH\< 4 for ≥ 4.5% of the time Note: Subjects will have discontinued any GERD medications for at least 10 days prior to testing.
• Subject has a symptomatic improvement on proton-pump inhibitor (PPI) therapy demonstrated by a GERD-Health-Related Quality of Life (GERD-HRQL) score of ≤ 10 on proton-pump inhibitors and ≥ 15 off PPIs, or subjects with a ≥ 6-point improvement when comparing his/her on-PPI and off-PPI GERD-HRQL score.
• Subject has GERD symptoms in absence of PPI therapy (minimum 10 days).
• If the subject is of child-bearing potential, she must have a negative pregnancy test within one week prior to implant and must agree to use effective means of birth control during the course of the study.
• Subject is willing and able to cooperate with follow-up examinations.
• Subject has been informed of the study procedures and the treatment and has signed an informed consent form.

You may not qualify if:

• The procedure is an emergency procedure.
• Subject is currently being treated with another investigational drug or investigational device.
• Subject has a history of gastroesophageal surgery, anti-reflux procedures, or gastroesophageal/gastric cancer.
• Subject has undergone any previous endoscopic anti-reflux intervention for GERD.
• Subject has suspected or confirmed esophageal or gastric cancer.
• Subject has any size hiatal hernia \>3cm as determined by endoscopy.
• Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg peristaltic amplitude on wet swallows or \<70% (propulsive) peristaltic sequences.
• Subject has esophagitis Grade C or D (LA Classification).
• Subject has a Body Mass Index (BMI)\>35.
• Subject has symptoms of dysphagia more than once per week within the last 3 months.
• Subject is diagnosed with Scleroderma or an esophageal motility disorder such as but not limited to Achalasia, Nutcracker Esophagus, or Diffuse Esophageal Spasm or Hypertensive LES.
• Subject has a history of or known esophageal stricture or gross esophageal anatomic abnormalities (Schatzki's ring, obstructive lesions, etc.).
• Subject has esophageal or gastric varices.
• Subject has a history of or known Barrett's esophagus.
• Subject cannot understand trial requirements or is unable to comply with the follow-up schedule.

Sponsors & Collaborators

• Aplos Medical: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (3)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

Keck Medical Center of University of Southern California

Los Angeles, California, 90033, United States

Location

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is an observational, prospective, non-randomized, open-label, feasibility study of patients receiving the Ω-Cuff device. The study is intended to evaluate the safety of the Ω-Cuff device and its ability to reduce the symptoms of GERD by augmenting the function of the LES. The study will be performed at up to three (3) investigational centers in the US with a maximum of 15 subjects who will be implanted with the device.

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 11, 2021
• Study Start: August 8, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)