NCT05697393 External UES Band (Shaker Pressure Band) and GERD
| NCT ID | NCT05697393 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical College of Wisconsin |
| Condition | Gastroesophageal Reflux |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2011-01-25 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 350 participants in total. It began in 2011-01-25 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Reza Shaker
PRINCIPAL INVESTIGATOR
Medical College of Wisconsin
Frequently Asked Questions
Who can join the NCT05697393 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Gastroesophageal Reflux. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05697393 currently recruiting?
Yes, NCT05697393 is actively recruiting participants. Contact the research team at rshaker@mcw.edu for enrollment information.
Where is the NCT05697393 trial being conducted?
This trial is being conducted at Milwaukee, United States.
Who is sponsoring the NCT05697393 clinical trial?
NCT05697393 is sponsored by Medical College of Wisconsin. The principal investigator is Reza Shaker at Medical College of Wisconsin. The trial plans to enroll 350 participants.