An interventional study of Cricopharyngeal myotomy and PH probe Testing in Laryngopharyngeal Reflux and Zenker's Diverticulum, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-26.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic
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Among 26 studies in Laryngopharyngeal Reflux with a site in United States — 3 open to participants now, 4 under way, none of them phase 3. Laryngopharyngeal Reflux · United States.
Among the 26 studies in Laryngopharyngeal Reflux with a site in United States, this one is the 16th largest by enrollment of the 21 interventional ones that give a count, is one of 3 that started in 2013, is one of 9 with no phase, and was the 16th registered.
56 studies on the registry are indexed under Laryngopharyngeal Reflux; 8 are open to participants now.
Browse Laryngopharyngeal Reflux studies →3 of the 26 studies in Laryngopharyngeal Reflux with a site in United States are open now. Recruiting first, the newest first:
Medical College of Wisconsin · Sites in United States
Ages 18–64
University of California, San Diego · Sites in United States
Ages 18–89
Johns Hopkins University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 5 Laryngopharyngeal Reflux studies recruiting now, 1 sets no upper age limit and 2 stop at 75 or younger; none take children under 18; none take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 2 · Phase 4 7
First in 2003; this study’s year is marked. 3 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 10 is below the median of 72 across 41 interventional studies indexed under Laryngopharyngeal Reflux.
Median enrollment 43 across the 21 interventional studies, 45 across the 5 observational. Of the 15 that completed or were terminated, 8 (53%) have results posted.
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4 of 26 have an industry lead sponsor. The 10 most frequent:
Mayo Clinic is the lead sponsor of 3,271 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Mayo Clinic has 1 study filed under Laryngopharyngeal Reflux — fewer than ten, so there is no comparison to draw.
1 of the studies in Laryngopharyngeal Reflux with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04383262Medical College of WisconsinFosamprenavir for Laryngopharyngeal Upper Airway Tissue Treatment and Enzyme Reduction | 2027-07-01 |
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Among the 26 studies in Laryngopharyngeal Reflux with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this study is to see if people with reflux with a Zenker's diverticulum have increased reflux into the throat following a cricopharyngeal myotomy.
Gastroesophageal reflux is considered to be a common cause of cricopharyngeal dysfunction and Zenker's diverticulum. In patients with severe symptoms of dysphagia, we perform a cricopharyngeal myotomy to release the tension at the upper esophageal sphincter. There has been some speculation that if the upper esophageal sphincter is severed, there could be an increase in reflux into the pharyngeal and laryngeal structures. The current gold standard for measuring laryngopharyngeal reflux (LPR) is 24 hour monitoring with a dual-electrode pH catheter. A newer device specifically measures LPR by sitting in the nasopharynx. The probe has been verified as accurate by several studies, with some postulating that since its recording intervals are closer together, it may be more accurate for measuring LPR. We aim to measure LPR with the new pH probe in patients with gastroesophageal reflux before and after cricopharyngeal myotomy to see if LPR becomes present or worsens after surgery.
All patients presenting with cricopharyngeal dysfunction or Zenker's diverticulum with a diagnosis or symptoms of gastroesophageal reflux or laryngopharyngeal reflux will be asked to participate in the study. If they meet the inclusion criteria, agree to participate, and wish to undergo surgery for their dysphagia, a baseline 24 hr laryngopharyngeal reflux study will be obtained using the Restech probe. Additionally, baseline dysphagia and reflux questionnaires will be obtained and an exam with flexible nasopharyngoscopy will be done. This exam is considered part of a standard exam for this condition and would be performed even if patients were not part of the research study. The surgical procedure will treat their dysphagia no differently than if they were not participating in the study. The patient will have their standard postoperative visit at 4 weeks, where their reflux and dysphagia symptoms will be assessed with questionnaires and a reflux finding score will be calculated via nasopharyngoscopy. At 3 months, an additional 24 laryngopharyngeal reflux study will be conducted with the Restech probe, and the patient will be seen in clinic for their final postoperative visit shortly thereafter. The questionnaires and the flexible nasopharyngoscopy for a reflux finding score will be repeated. The nasopharyngoscopy exam is standard of care for this patient visit. The patient would undergo the same number of nasopharyngoscopies even if they were not part of the study. During the study, if the patient is already on medication for reflux, they will be taken off their medication for 7 days in order to better detect changes in their LPR before and after cricopharyngeal myotomy. This is the standard protocol for patients being tested for LPR by the 24 hr pH probe study with the Restech probe. The patients will serve as their own controls as we are looking for significant increases in the amount of laryngopharyngeal reflux after cricopharyngeal myotomy. The data will be maintained in a database until the end of the study.
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Exclusion Criteria:
Subjects scheduled to undergo an endoscopic criocopharyngeal myotomy, which is the standard treatment for a Zenker's diverticulum, will have levels of laryngopharyngeal reflux measured after the procedure.
Procedure: Cricopharyngeal myotomy · Diagnostic Test: PH probe Testing
Endoscopic laser cricopharyngeal myotomy is one of the standard treatments for Zenker's Diverticulum. It takes about 30 minutes and at our institution requires a one night of observation in the hospital.
24 hour PH probe testing, which will measure acid reflux following cricopharyngeal myotomy.
Presence of LPR measured by: number of pH drops >3 standard deviations from baseline and the pharyngeal composite pH score.
Time frame: 3 months postoperatively
Reflux symptom index (RSI) score
Time frame: 3 months postoperatively
Mayo Dysphagia Questionnaire Score
Time frame: 3 months postoperatively
Reflux finding score
Time frame: 3 months postoperatively
The record gives a start of Jun 2013, a primary completion of Jan 2018 and a completion of Jan 2018. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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