Using a band to reduce nighttime reflux symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.