Using a band to reduce nighttime reflux symptoms
External Upper Esophageal Sphincter Band (Shaker Pressure Band) and Gastroesophageal Reflux Disease
This study is testing if a special band worn around the throat can help people with GERD feel better at night and reduce their reflux symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT05697393 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an external upper esophageal band, known as the Shaker Pressure Band, in alleviating nighttime symptoms associated with gastroesophageal reflux disease (GERD). GERD affects a significant portion of the population and can lead to complications beyond the esophagus, including issues in the throat and lungs. The study aims to explore the physiological interactions between the esophagus and pharynx during reflux episodes, particularly focusing on how the band may prevent aspiration and related complications. Participants will be monitored for improvements in their symptoms and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with GERD who experience throat-related symptoms such as chronic cough or regurgitation.
Not a fit: Patients with sleep apnea, previous head or neck surgeries, or significant bleeding disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce nighttime reflux symptoms and prevent serious complications associated with GERD.
How similar studies have performed: While the approach of using an external band for reflux management is relatively novel, similar studies exploring non-invasive interventions for GERD have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milwaukee, Wisconsin
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Reza Shaker — Medical College of Wisconsin
- Study coordinator: Reza Shaker, MD
- Email: rshaker@mcw.edu
- Phone: 4149556840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.