Status:
ACTIVE_NOT_RECRUITING
Reflux Band in Laryngopharyngeal Reflux
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Laryngopharyngeal Reflux
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
This 12 week biomarker targeted double blind randomized controlled trial (RCT) will enroll subjects with salivary pepsin positive laryngopharyngeal reflux (LPR) to assess efficacy of the external uppe...
Detailed Description
This study seeks to understand if the Reflux Band is an effective treatment for laryngopharyngeal reflux (LPR) in comparison to a sham device. LPR is a syndrome in which acid that is made in the stoma...
Eligibility Criteria
Inclusion
- Adults between 18-99, English or Spanish speaking
- ≥8 weeks of laryngeal symptoms (dysphonia, throat clearing, cough, globus, and/or sore throat)
- Current use of double daily dose acid suppression therapy (ex. omeprazole 40mg, omeprazole 20mg and famotidine 20mg)
- Laryngoscopic exam prior to screening with current symptoms
- At least 1 of the following:
- Elevated reflux testing
- Findings on upper endoscopy that are consistent with pathologic GERD
- Fasting pepsin analysis result of ≥25 ng/mL within 4 months of enrollment (12 months if treatment plan has not changed) \*testing allowed at enrollment if not previously obtained
Exclusion
- Prior use of Reflux Band (UES Compression Device)
- Sino-pulmonary conditions (such as asthma, COPD, post-nasal drip, heavy voice use) as primary etiology of laryngeal symptoms as deemed by treating gastroenterologist and / or laryngologist
- Laryngeal mass or lesion on laryngoscopy
- Pregnant or breastfeeding
- Unable to consent in English or Spanish
- Imprisoned
- Patients with a prior foregut surgery
- Patients with a known achalasia diagnosis
- Inability to fast for 4 hours
- Active tobacco use
- Supplemental oxygen use
- Contraindication to UES Compression Device manufacturer guidelines:
- Patients with implants or implant parts that reside in the area where Reflux Band is applied: implanted pacemarker, implanted cardioverter defibrillator (ICD), vagus nerve stimulator (VNS), or other such devices implanted in the neck
- Patients diagnosed with glaucoma.
- Patients who had a malignancy of the neck, including neck surgery.
- Patients that may have an altered mental status including due to the use of sedative drugs or narcotics.
- Patients with carotid artery disease, uncontrolled thyroid disease, a history of cerebrovascular disease, or connective tissue disorder of Marfan's Syndrome or Ehlers-Danlos Syndrome
- Patients who use nocturnal NIV machines such as CPAP or BiPAP.
Key Trial Info
Start Date :
May 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04827355
Start Date
May 7 2021
End Date
April 30 2026
Last Update
April 8 2025
Active Locations (1)
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1
University of California, San Diego
La Jolla, California, United States, 92037