Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03619811
Other study ID # 18-0205
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 13, 2018
Est. completion date June 30, 2021

Study information

Verified date August 2021
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study plans to learn more about reflux associated laryngeal symptoms, and more efficient ways to diagnose and treat this condition.


Description:

Reflux associated laryngeal symptoms, coined "laryngopharyngeal reflux", occurs when gastro-esophago-pharyngeal reflux contributes to chronic laryngeal symptoms such as throat clearing, sore throat and dysphonia. Over the past 25 years, Reflux associated laryngeal symptoms has been increasingly, and often incorrectly, diagnosed and has emerged as a point of controversy and confusion.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria: - Age 18-89 years male and female, - >8 weeks of symptoms of sore throat, throat clearing, and/or voice hoarseness, - naïve to PPI or able to stop for 8 weeks Exclusion Criteria: - Laryngeal mass lesion on laryngoscopy; - Pregnant; - Unable to consent in English; - Imprisoned; - PPI intolerance; - Contraindication to UESAD use per manufacturer guidelines which include: - Patients with implants or implant parts that reside in the area where UESAD is applied. - Patients with an implanted pacemaker, implanted cardioverter defibrillator (ICD), vagus nerve stimulator, or other such similar 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, thyroid disease, a history of cerebrovascular disease, or any disorder of connective tissues (e.g., Marfan's Syndrome or Ehlers-Danlos Syndrome). - Patients who use nocturnal NIV machines such as CPAP or BiPAP.

Study Design


Intervention

Diagnostic Test:
Reflux Band® Upper Esophageal Sphincter (UES) Assist Device
UES augmentation via the UES assist device is effective in true Reflux associated laryngeal symptoms. In our first pilot trial with the UES assist device, patients had significant symptom reduction following 2 weeks of UES assist device use. Based on our preliminary work, we theorize that the UES assist device is effective in Reflux associated laryngeal symptoms.

Locations

Country Name City State
United States University of California, San Diego La Jolla California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score Response will be assessed binary as positive or negative where a positive response is defined by a post-treatment reflux symptom index (RSI) score = 13 and a 33% change from comparator RSI. The minimum value is 0 and the maximum value is 45. The lower the score means less reported symptoms and the higher the score means more reported symptoms. Week 8 (Completion)
Primary Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score Response will be assessed binary as positive or negative where a positive response is defined by a post-treatment reflux symptom index (RSI) score = 13 and a 33% change from comparator RSI. The minimum value is 0 and the maximum value is 45. The lower the score means less reported symptoms and the higher the score means more reported symptoms. Week 4
See also
  Status Clinical Trial Phase
Recruiting NCT05561179 - Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease N/A
Withdrawn NCT02213887 - Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications Phase 4
Completed NCT01946971 - Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER) Phase 1/Phase 2
Recruiting NCT01825473 - Study of Erythromycin in GER-Associated Apnea of the Newborn N/A
Completed NCT00614536 - Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period Phase 4
Completed NCT00373997 - Esophageal and Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux Phase 4
Completed NCT00284908 - Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers Phase 1
Completed NCT00365300 - Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD) Phase 3
Completed NCT00215787 - Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease N/A
Completed NCT01167543 - Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease N/A
Completed NCT00226044 - Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants. Phase 3
Completed NCT00141960 - Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease Phase 2/Phase 3
Completed NCT00291746 - Validation of RDQ Questionnaire Phase 4
Completed NCT00567021 - German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms N/A
Completed NCT01048840 - Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age
Completed NCT00181805 - Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents
Terminated NCT01281553 - A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease Phase 4
Completed NCT05486169 - Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy N/A
Completed NCT04034017 - Gastroesophageal Reflux Disease Among College Students
Terminated NCT03226054 - Determining Risk Factors for Successful PPI Weaning N/A