External Upper Esophageal Sphincter (UES) Compression Device for Laryngopharyngeal Reflux

University of California, San Diego, La Jolla, CA
Laryngopharyngeal RefluxExternal Upper Esophageal Sphincter (UES) Compression Device - Device
18 - 99
All Sexes
What conditions do you have?

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

Eligible Conditions
  • Laryngopharyngeal Reflux (LPR)

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 5 years

5 years
Measure pepsin response to the UES Compression Device in pepsin positive LPR.
Measure response to the UES Compression Device in pepsin positive LPR.

Trial Safety

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Experimental Treatment

Non-Treatment Group

72 Total Participants · 2 Treatment Groups

Primary Treatment: External Upper Esophageal Sphincter (UES) Compression Device · Has Placebo Group · N/A

Experimental Group · 1 Intervention: External Upper Esophageal Sphincter (UES) Compression Device · Intervention Types: Device
ShamComparator Group · 1 Intervention: Sham Device · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,212 Previous Clinical Trials
4,193,611 Total Patients Enrolled
University of California, San DiegoLead Sponsor
1,050 Previous Clinical Trials
1,827,303 Total Patients Enrolled
1 Trials studying Laryngopharyngeal Reflux
43 Patients Enrolled for Laryngopharyngeal Reflux
Rena Yadlapati, MD, MSHSPrincipal Investigator - UC San Diego Health
University of California, San Diego

Eligibility Criteria

Age 18 - 99 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been experiencing laryngeal symptoms such as hoarseness, cough, sore throat, or feeling of a lump in your throat for at least 8 weeks.

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.