ACTIVE_NOT_RECRUITING

Omega Cuff for GERD Feasibility Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-08-08

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04793035

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 74 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* • 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.

Inclusion Criteria

Exclusion 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.

* • 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.

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Aplos Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-08

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2023-08-08

Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

GERD, Acid Reflux, Treatment