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NCT04827355 · ClinicalTrials.gov registry record · NA
Reflux Band in Laryngopharyngeal Reflux
A NA study of Laryngopharyngeal Reflux, sponsored by University of California, San Diego.
- Active
- Registry status
- NA
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT04827355: Active NA study of Laryngopharyngeal Reflux, sponsored by University of California, San Diego.
NCT04827355 is a NA study of Laryngopharyngeal Reflux that is active but no longer recruiting, run by University of California, San Diego. The registered enrollment target is 72 participants, below the 99-participant average among 3 other Laryngopharyngeal Reflux trials with a reported enrollment target (27% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04827355, a NA study of Laryngopharyngeal Reflux, is active but no longer recruiting, sponsored by University of California, San Diego.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study 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 upper esophageal sphincter (UES) compression device, also known as the Reflux Band. Subjects will be randomized to one of two arms: control or experimental. Following the 8 week intervention period subjects in both arms will continue in a 4 week unblinded period. 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.
Primary Outcome
Change in reflux symptom index score (primary outcome) between intervention versus sham arm will determine device efficacy.
Conditions Studied
Interventions
- DEVICE Sham Device
- DEVICE External Upper Esophageal Sphincter (UES) Compression Device
Study Locations (1)
California
- University of California, San Diego - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2021-05-07 |
| Est. Completion | 2026-04-30 |
| Phase | NA |
What the registry record for NCT04827355 still lists
NCT04827355 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 99-participant average among 3 other Laryngopharyngeal Reflux trials with a reported enrollment target (27% lower).
The record links to 1 condition, with Laryngopharyngeal Reflux appearing as the primary indexed condition, and to 2 interventions - of which Sham Device is the first listed.
NCT04827355 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04827355 about?
NCT04827355 is a clinical study titled "Reflux Band in Laryngopharyngeal Reflux". 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 upper esophageal sphincter (UES) compression device, also known as the Reflux Band. Subjects will be ran...
What is the current status of trial NCT04827355?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 72 participants. The study started on 2021-05-07. Estimated completion is 2026-04-30.
What conditions does trial NCT04827355 study?
This clinical trial studies the following conditions: Laryngopharyngeal Reflux.
What interventions are being tested in trial NCT04827355?
The interventions under investigation include: Sham Device (DEVICE), External Upper Esophageal Sphincter (UES) Compression Device (DEVICE).
Who is sponsoring clinical trial NCT04827355?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04827355 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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