External UES Band (Shaker Pressure Band) and GERD

Launched by MEDICAL COLLEGE OF WISCONSIN · Jan 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a special external band designed to help reduce nighttime symptoms related to gastroesophageal reflux disease (GERD). GERD can cause symptoms like coughing, choking, or food coming back up into the throat, especially at night. The goal of the study is to see if this band can effectively decrease these uncomfortable symptoms.

To participate in this trial, you must be at least 18 years old and have been diagnosed with GERD along with some related symptoms. However, if you are pregnant, have certain health conditions like sleep apnea, or have had specific surgeries on your head or neck, you may not be eligible. If you join the study, you’ll be monitored to see how the band affects your symptoms. This trial is currently recruiting participants, and it aims to help improve the quality of life for those suffering from GERD.

Gender

ALL

Eligibility 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.