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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?
Aplos MedicalLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,233 Total Patients Enrolled
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is eligibility for this trial open to those above the age of twenty?
"This clinical trial is accepting participants that are between 22 and 74 years old."
Answered by AI
What are the eligibility requirements to participate in this research initiative?
"Those with gastroesophageal reflux disease, aged between 22 and 74 years old, are eligible to participate in this research. The study requires a cohort of 15 individuals."
Answered by AI
Are applicants being accepted for this trial at present?
"As reported on clinicaltrials.gov, this medical study is actively reaching out to potential recruits. The investigation was initially set up on April 1st 2023 and had its most recent update on the 3rd of the same month."
Answered by AI
What is the aggregate number of participants involved in this medical experiment?
"Affirmative, the information found on clinicaltrials.gov confirms that this experiment is presently seeking volunteers. The trial was first posted on April 1st 2023 and has been revised recently as of April 3rd 2023. This study requires 15 individuals at a single location to participate in it."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Keck Medical Center of University of Southern California
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
3+
Why did patients apply to this trial?
I am on 40 mg daily nexium and I will still often wake in my sleep choking on my own stomach acids.
PatientReceived 1 prior treatment
Continuing issues with acid reflux, I just want to find a solution and be able to live a normal life.
PatientReceived no prior treatments
I have been on high dose Nexium Rx for a very long time with intermittent success. I have had no success with OTC medications. I had an endoscopy done about 10 years ago which showed damage to my esophagus but was unable.
PatientReceived 1 prior treatment
I have been on high-dose nexium for years. Decades really. I've tried several other medications like Prilosec and other OTC options and nothing helped. I am reaching the point where the nexium doesn't help. A frequently wake up choking on my own bile, my throat burning, and that disgusting bitter taste. I had an endoscopy done 12 or 13 years ago when I lived in Chicago which showed multiple points of erosion. But, finances and insurance left me no options to treat it.
Just taking meds doesn't work anymore. A few doctors have said that I need to stop taking the nexium as it can impact vitamin d absorption which is especially bad for women my age. I need something that works. And I need something that I can afford to do with basically no help from the American medical industrial complex and for-profit insurance companies.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long does the surgery take and do you have to spend a lot of time in the hospital after the procedure?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Email
Most responsive sites:
- Keck Medical Center of University of Southern California: < 24 hours
Average response time
- < 1 Day
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