External UES Band (Shaker Pressure Band) and GERD
ConditionGastroesophageal Reflux
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorMedical College of Wisconsin
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Shaker Pressure Band
Treatment groups
350 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov