Trial reportClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2026
Randomized Controlled Trial of Upper Esophageal Sphincter Assist Device in Laryngopharyngeal Reflux Disease.
Trial report in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04827355 (Randomized Sham-Controlled Trial of the Reflux Band in Laryngopharyngeal Reflux), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized Sham-Controlled Trial of the Reflux Band in Laryngopharyngeal Reflux (LPR)
Who cites it
1 citing paper in PubMed.
- Laryngopharyngeal Symptoms and Laryngopharyngeal Reflux Disease: Interdisciplinary Considerations and Management.Neurogastroenterology and motility · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
BACKGROUND &
aimsEffective therapies for laryngopharyngeal reflux disease (LPRD) are limited. The noninvasive upper esophageal sphincter assist device (UESAD) applies external cricoid pressure to prevent esophago-pharyngeal reflux events and has been associated with symptom improvement in uncontrolled single-arm studies. We aimed to conduct the first randomized controlled trial of the UESAD in patients with LPRD refractory to anti-secretory therapy.
methodsEnrolled adults with objective LPRD and ≥8 weeks of laryngopharyngeal symptoms despite anti-secretory therapy were randomly assigned 1:1 to 8 weeks of intervention (UESAD applying therapeutic pressure [20-30 mm Hg]) or comparator (UESAD applying low pressure [4-11 mm Hg]), followed by an optional 4-week open-label extension. The primary outcome was change in reflux symptom index (RSI); secondary outcomes included salivary pepsin concentration and adverse events.
resultsOf 72 participants enrolled, 68 were randomized: mean age, 56.0 years (standard deviation [SD], 16.4 years); 60.3% female; body mass index, 26 kg/m
conclusionsIn this randomized double-blinded controlled trial of patients with LPRD, significant differences in laryngopharyngeal symptoms were not seen between application of the UESAD at therapeutic vs lower pressures. Laryngopharyngeal symptoms as well as pepsin concentrations significantly improved among both groups, suggesting that application of external cricoid pressure, even at lower levels, is a safe, noninvasive, well-tolerated, and effective therapy for LPRD. CLINICALTRIALS: gov, Number: NCT04827355.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.