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Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) Study in Ulcerative Colitis
Sponsor: Cala Health, Inc.
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.
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
Key Details
Gender
All
Age Range
10 Years - 39 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2023-01-12
Completion Date
2026-04-15
Last Updated
2026-10-22
Healthy Volunteers
No
Conditions
Interventions
RAVANS
Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation
RAVANS-sham
RAVANS sham device
Locations (1)
Feinstein Institute for Medical Research at Northwell Health
Lake Success, New York, United States