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Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) Study in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:
Investigating the Safety and Efficacy of Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) in Ulcerative Colitis (UC) in Pediatric and Young Adult Populations

Clinical Trial Summary

Prospective, single-center, sham-controlled, double-blinded 12-week study designed to evaluate the safety and efficacy of the RAVANS device in subjects with Ulcerative Colitis. The goal of the study is to distinguish sham (no stimulation) versus treatment (stimulation) response and to identify treatment responders. The study will last 12 weeks with in-clinic visits at 0 weeks and 12 weeks, and a telehealth-visit at week 6. Additionally, unscheduled visits may occur based on the needs of the subject or at the discretion of the investigator. Subjects will be randomized 2:1 to treatment or sham, and will stimulate at home twice per day.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05662059
Study type Interventional
Source Cala Health, Inc.
Contact Jillian Charyn
Phone 516-472-3691
Email jcharyn@northwell.edu
Status Recruiting
Phase N/A
Start date January 12, 2023
Completion date December 30, 2023
View Details
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