External UES Band (Shaker Pressure Band) and GERD (NCT05697393) | Clinical Trial Compass
RecruitingNot Applicable
External UES Band (Shaker Pressure Band) and GERD
United States350 participantsStarted 2011-01-25
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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.
What they're measuring
1
Symptom Analysis
Timeframe: Initial physician assessment and after one week of treatment