Your session is about to expire
← Back to Search
Reflux Band for Acid Reflux
Study Summary
This trial will test a device to help people with laryngopharyngeal reflux, a type of acid reflux. The device, called the Reflux Band, is worn around the neck and compresses the upper esophageal sphincter to prevent reflux. The trial will enroll subjects with salivary pepsin positive LPR and will be double blind, meaning that neither the subjects nor the researchers will know who is in the control or experimental groups. The primary hypothesis is that a significantly higher proportion of subjects in the experimental arm will meet the primary endpoint for symptom response, compared to subjects in the control arm
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I am between 18 and 99 years old and speak English or Spanish.I have carotid artery disease, uncontrolled thyroid disease, a history of stroke, or Marfan's/Ehlers-Danlos Syndrome.My mental status may be altered due to sedatives or narcotics.I have had cancer or surgery in my neck area.I have been diagnosed with glaucoma.I use a CPAP or BiPAP machine at night.This criterion means that you need to meet at least one of the listed requirements.I have had symptoms like voice changes or sore throat for over 8 weeks.I have a growth in my voice box seen during an examination.My fasting pepsin level was 25 ng/mL or higher recently.You currently smoke or use tobacco products.I use supplemental oxygen.I have been diagnosed with achalasia.I am currently taking a high dose of acid suppression medication daily.You can't go without eating for 4 hours.I have had a throat exam because of my current symptoms.You have a test showing that you have a lot of reflux.You have signs of a condition called GERD during an upper endoscopy.You have medical devices implanted in your neck area that could be affected by the Reflux Band.I cannot give consent in English or Spanish.My throat symptoms are mainly due to conditions like asthma or COPD.I have had surgery on my upper digestive tract before.You have used the Reflux Band (UES Compression Device) before.
- Group 1: Control
- Group 2: Experimental
- 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.
Frequently Asked Questions
Is recruitment open for this clinical investigation?
"A review of clinicaltrials.gov reveals that this research initiative, first posted on May 7th 2021, is presently recruiting volunteers. This trial was last modified in November 2022."
Are there certain prerequisites that must be met in order to participate in this research trial?
"This research is actively seeking 72 participants between 18-99 years old who suffer from regurgitation, gastric issues. Key qualifications include: being an adult aged 18-99, English or Spanish fluency, regular usage of double dose PPI*, laryngoscopic exam within the last year with a reflux score higher than 7, elevated reflux testing results and fasting pepsin analysis result ≥25 ng/mL (within 4 months or 12 if treatment plan has been changed)*, 8+ weeks suffering from dysphonia, throat clearing, coughs etc., findings on upper endoscopy that are indicative of pathological GERD."
Does this research endeavor accept individuals older than twenty years of age?
"This trial is only open to individuals between 18 and 99 years old; for minors or seniors, there are 15 and 53 studies respectively."
Who else is applying?
What portion of applicants met pre-screening criteria?
What site did they apply to?
Why did patients apply to this trial?
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger