RecruitingNot ApplicableNCT05697393
External UES Band (Shaker Pressure Band) and GERD
External Upper Esophageal Sphincter Band (Shaker Pressure Band) and Gastroesophageal Reflux Disease
Sponsor
Medical College of Wisconsin
Enrollment
350 participants
Start Date
Jan 25, 2011
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 85 Years
Inclusion Criteria4
- 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 Criteria7
- The patient cannot be younger than 18 years of age or older than 85.
- The patient cannot have sleep apnea or be on CPAP
- Patient 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 contraindicated
- Patients with a known esophageal obstruction prevent passage of the manometry probe.
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Interventions
DEVICEShaker Pressure Band
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05697393
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