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Recruiting NCT05695846

Diagnostic Tests in Supra-Esophageal Gastroesophageal Reflux Disease (SE-GERD)

Conditions: Gastroesophageal Reflux

Sex: All
Ages: 20 Years – 85 Years
Phase: NA
Enrollment: 90
Sponsor: Medical College of Wisconsin

Location: United States

Summary

After defining the manometric characteristics of UES incompetence associated with documented pharyngeal reflux, we will determine the reproducibility of manometric criteria for UES incompetence in prevention of pharyngeal reflux. We hypothesize that these criteria are comprised of either a single or constellation of manometric abnormalities. After determining the ability of externally applied cricoid cartilage pressure in preventing pharyngeal reflux, we further hypothesize that this approach will eliminate or reduce esophago-pharyngeal reflux by enhancing the UES pressure barrier. We anticipate there will be a close spatial correlation between the site of applied pressure and area of increased pressure within UES high pressure zone. Lastly, we will determine and characterize the effect of externally applied cricoid cartilage pressure on related functions such as belch and swallow, testing the hypothesis that these functions will not be impaired.

Eligibility Criteria

Inclusion Criteria:GERD patients with complaints of regurgitation and supra-esophageal symptoms will be included Patient definition will be based on position statement and technical reviews of the American Gastroenterological Association and Montreal definition and classification of gastroesophageal and reflux disease (Am J Gastroenterol. 2006;101:1900-1920).Exclusion Criteria:Age <20 or >85History or active alcohol or drug abuseHistory of upper GI and ears, nose, throat and pulmonary diseases that may affect the oropharyngoesophageal axis and stomachHistory of malignancy and chemo-radiation therapyUnable to give consentPregnant women (see justification in the Women and Minority Inclusion in Clinical Research section).History of allergy to Lidocaine for nasal topical anesthesia.

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Source: ClinicalTrials.gov (NCT05695846). StuddyBuddy aggregates publicly available trial information.