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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Shaker Pressure Band
Device
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: Shaker Pressure Band GERD patients with external laryngeal pressureActive comparator 1 intervention
Group B: Shaker Pressure Band GERD patients without external laryngeal pressurePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Symptom Analysis
Patients will be evaluated and categorized by their symptoms at the time of their clinical physician's assessment. All patients will then undergo the same study procedures already approved for this protocol and evaluate the change in their symptoms using the evaluation forms currently available in this protocol.
Time frame
Initial physician assessment and after one week of treatmentSponsors and contacts
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Source ClinicalTrials.gov