External Upper Esophageal Sphincter Band (Shaker Pressure Band) and Gastroesophageal Reflux Disease
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• 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.
Locations
United States
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Reza Shaker, MD
rshaker@mcw.edu
4149556840
Backup
Mark Kern
mkern@mcw.edu
4148053826
Time Frame
Start Date: 2011-01-25
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 350
Treatments
Active_comparator: Shaker Pressure Band GERD patients with external laryngeal pressure
One week of Shaker pressure band
Placebo_comparator: Shaker Pressure Band GERD patients without external laryngeal pressure
One week of sham Shaker pressure band (no external laryngeal pressure)
Related Therapeutic Areas
Sponsors
Leads: Medical College of Wisconsin