Using Omega-Cuff to treat acid reflux

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

This study is testing a new device called the Omega-Cuff to see if it can help people with acid reflux feel better without changing their anatomy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 22 Years to 74 Years
• Sex: All
• Sponsor: Aplos Medical (industry)
• Locations: 4 sites (Scottsdale, Arizona and 3 other locations)
• Trial ID: NCT04793035 on ClinicalTrials.gov

What this trial studies

This clinical feasibility study evaluates the Omega-Cuff device for treating gastroesophageal reflux disease (GERD) in patients. The Omega-Cuff is a nitinol device placed laparoscopically around the esophageal sphincter to enhance its function without altering anatomy. The study aims to assess the device's performance and safety over a one-year follow-up period in patients who have been experiencing GERD symptoms for at least six months. The device is designed to increase resistance to acid reflux while allowing normal swallowing.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 to 75 with documented GERD symptoms requiring daily medication and who are suitable for laparoscopic surgery.

Not a fit: Patients with mild GERD symptoms or those who do not require medication for acid reflux may not benefit from this study.

Why it matters

Potential benefit: If successful, this device could provide a new, effective treatment option for patients suffering from GERD who do not respond well to medication.

How similar studies have performed: While similar surgical interventions have shown success, the Omega-Cuff approach is relatively novel and has not been extensively tested in clinical settings.

Eligibility criteria

Inclusion Criteria:

* • 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.

Exclusion Criteria:

* • 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.
  * Subject is pregnant or nursing or plans to become pregnant during the course of the study.
  * Subject has a medical illness (e.g., congestive heart failure) that may cause the subject to be non-compliant with or unable to meet the protocol requirements or is associated with limited life expectancy (i.e., less than 3 years).
  * Subject is diagnosed with a psychiatric disorder (e.g., bipolar, schizophrenia, etc.); however, subjects who exhibit depression but are on appropriate medication(s) may be included.
  * Subject has suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
  * Subject has an electrical implant or metallic abdominal implants.
  * Subject is not a surgical candidate for open laparotomy.

Where this trial is running

Scottsdale, Arizona and 3 other locations

• HonorHealth — Scottsdale, Arizona, United States (RECRUITING)
• Keck Medical Center of University of Southern California — Los Angeles, California, United States (RECRUITING)
• SOFI Research/Foregut Research Foundation — Lone Tree, Colorado, United States (WITHDRAWN)
• University of Texas at Austin — Austin, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Claude Tihon, PhD

Conditions: GERD, Acid Reflux, Treatment