Actively Recruiting
External Upper Esophageal Sphincter Band (Shaker Pressure Band) and Gastroesophageal Reflux Disease
Led by Medical College of Wisconsin · Updated on 2026-03-09
350
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Gastroesophageal reflux disease (GERD) is a common condition affecting the esophagus and can cause symptoms beyond the esophagus, such as throat, airway, and lung problems. This research evaluates the use of an external upper esophageal sphincter (UES) band, known as the Shaker Pressure Band, to reduce nighttime symptoms caused by reflux into the throat. The study aims to better understand how increasing pressure at the UES might limit reflux and improve symptoms in patients with GERD who continue to experience symptoms despite medical treatment. Participants will use the Shaker Pressure Band device for one week, which applies external pressure at the level of the cricoid cartilage to increase UES pressure to 20 mmHg. The study is randomized and compares one week of active treatment with the band applying pressure against one week using a sham band that does not apply pressure. This design helps assess whether the external band can reduce reflux-related symptoms by limiting reflux into the throat. During the study, participants will undergo an initial physician assessment and symptom analysis after each treatment week to evaluate changes. Researchers will monitor subjective symptoms related to reflux, such as heartburn, cough, choking, and sleep disturbances. Participants will be followed for safety and symptom changes throughout the treatment periods. The total study duration includes one week of treatment with each band type and symptom assessments to measure the impact of the external band on reflux symptoms.
CONDITIONS
Brief Title
External UES Band (Shaker Pressure Band) and GERD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient must be 18 years of age or older.
- Patients with gastroesophageal reflux disease who have ear, nose, and throat symptoms, chronic cough, choking, or regurgitation.
- Diagnosis of GERD with extra-esophageal symptoms, esophagitis, hiatal hernia, achalasia, or diffuse esophageal spasm.
- The patient must not be pregnant or lactating.
You will not qualify if you...
- 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 unable to tolerate nasal intubation.
- Patients with significant bleeding disorders contraindicating nasal intubation.
- Patients with esophageal obstruction preventing manometry probe passage.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 week
Participants use the Shaker Pressure Band or a sham band to apply external laryngeal pressure to reduce reflux symptoms.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53086
Actively Recruiting
Research Team
R
Reza Shaker, MD
M
Mark Kern
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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