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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial evaluates a device that may permanently reduce acid reflux in GERD patients without interfering with normal food swallowing. It will assess the device's safety profile and if it can be safely removed if needed.
Who is the study for?
This trial is for adults aged 22-75 with chronic GERD symptoms, who respond to proton-pump inhibitors but still experience significant acid reflux (pH<4 over 4.5% of the time). Candidates must be able to undergo surgery and agree to birth control if applicable. Exclusions include previous gastroesophageal surgeries, large hiatal hernias, severe esophagitis, high BMI (>35), certain motility disorders, metal allergies, and those with implants that could interfere.Check my eligibility
What is being tested?
The Omega-Cuff device is being tested in this study. It's a permanent implant placed laparoscopically at the esophageal sphincter to help prevent acid reflux without affecting swallowing. The study aims to assess its functionality and safety in up to 15 patients over a year.See study design
What are the potential side effects?
Potential side effects may include discomfort or complications from surgery, reactions specific to the implant material such as irritation or allergic response (in case of undiagnosed metal allergy), and possible issues related to general anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 22 and 75 years old with an expected lifespan of more than 3 years.
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My acid reflux symptoms improve significantly with PPI medication.
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I take daily medication for acid reflux.
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I am fit for surgery and can undergo general anesthesia.
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My acid reflux test shows pH<4 for more than 4.5% of the time without GERD medication for 10 days.
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I have had symptoms like heartburn or acid reflux for more than 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Outcome 1
Outcome 2
Outcome 3
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Enrolled patientsExperimental Treatment1 Intervention
Single-arm study for enrolled GERD patients to be treated with an Omega-Cuff device
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,376 Previous Clinical Trials
4,315,759 Total Patients Enrolled
Aplos MedicalLead Sponsor
CT Resources, IncLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a known issue with my esophagus, like a stricture or abnormal shape.I understand the trial requirements and can follow the schedule.I am between 22 and 75 years old with an expected lifespan of more than 3 years.My acid reflux symptoms improve significantly with PPI medication.I take daily medication for acid reflux.I do not have a serious illness that could stop me from following the study rules or that limits my life expectancy to under 3 years.My procedure is classified as an emergency.I am fit for surgery and can undergo general anesthesia.My esophagus has weak muscle movements.I have a hiatal hernia larger than 3cm.I have severe esophagitis.I have been diagnosed with Scleroderma or a disorder affecting how my esophagus moves.I have been diagnosed with Barrett's esophagus.I have had surgery for acid reflux, stomach issues, or stomach cancer.My acid reflux test shows pH<4 for more than 4.5% of the time without GERD medication for 10 days.I have varicose veins in my esophagus or stomach.I have had trouble swallowing more than once a week in the last 3 months.I have a psychiatric condition but am stable on medication if it's depression.I have had a procedure to treat acid reflux.I have or might have cancer in my esophagus or stomach.I cannot undergo major abdominal surgery.I have had GERD symptoms without taking PPIs for at least 10 days.I have had symptoms like heartburn or acid reflux for more than 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Enrolled patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Gastroesophageal Reflux Disease Patient Testimony for trial: Trial Name: NCT04793035 — N/A
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