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Recruiting
NCT05697393
External UES Band (Shaker Pressure Band) and GERD
Conditions: Gastroesophageal Reflux
Sex: All
Ages: 18 Years – 85 Years
Phase: NA
Enrollment: 350
Sponsor: Medical College of Wisconsin
Location: United States
Summary
This protocol is a study to assess the efficacy of an external upper esophageal band to decrease subjective nighttime symptoms related to esophageal reflux into the pharynx.
Eligibility Criteria
Inclusion Criteria:The patient must be 18 years of age or older.Patients with gastroesophageal reflux disease (GERD) who has ear, nose, and throat symptoms, chronic cough, choking, or regurgitation (food coming back up into the throat).The patient has been diagnosed with GERD with extra-esophageal symptoms, esophagitis, hiatal hernia, achalasia, or diffuse esophageal spasm.The patient must not be pregnant or lactating.Exclusion Criteria:The patient cannot be younger than 18 years of age or older than 85.The patient cannot have sleep apnea or be on CPAPPatient cannot have previous head or neck surgery or radiation.Patient cannot have carotid artery disease, thyroid disease or history of cerebral vascular disease.Patients with an inability to tolerate nasal intubation.Patients with significant bleeding disorders for whom nasal intubation has been deemed contraindicatedPatients with a known esophageal obstruction prevent passage of the manometry probe.
Source: ClinicalTrials.gov (NCT05697393). StuddyBuddy aggregates publicly available trial information.