NCT05662059

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Cala Health, Inc. · Industry
• Sex: All
• Age: 10 Years – 39 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DEVICE	RAVANS	Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation
DEVICE	RAVANS-sham	RAVANS sham device

Timeline

• Start date: 2023-01-12
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2022-12-22
• Last updated: 2023-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study