Status:
ACTIVE_NOT_RECRUITING
Omega Cuff for GERD Feasibility Study
Lead Sponsor:
Aplos Medical
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
GERD, Acid Reflux, Treatment
Eligibility:
All Genders
22-74 years
Phase:
NA
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 i...
Detailed Description
Gastroesophageal Reflux Disease (GERD) is a chronic excessive stomach content reflux that results in heartburn with major adverse impacts on patient quality of life. It is increasingly common in indus...
Eligibility Criteria
Inclusion
- • 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
- • 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.
Key Trial Info
Start Date :
August 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04793035
Start Date
August 8 2023
End Date
March 31 2026
Last Update
September 10 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
HonorHealth
Scottsdale, Arizona, United States, 85258
2
Keck Medical Center of University of Southern California
Los Angeles, California, United States, 90033
3
University of Texas at Austin
Austin, Texas, United States, 78712