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COMPLETED
NCT05662059
NA

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

Sponsor: Cala Health, Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

RAVANS

Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation

DEVICE

RAVANS-sham

RAVANS sham device

Locations (1)

Feinstein Institute for Medical Research at Northwell Health

Lake Success, New York, United States