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

Cala Health, Inc.1 site in 1 country30 target enrollmentJanuary 12, 2023

ConditionsUlcerative Colitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ulcerative Colitis
Sponsor: Cala Health, Inc.
Enrollment: 30
Locations: 1
Primary Endpoint: Clinical Remission
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 12, 2023

End Date

December 30, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cala Health, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 10-39 years
•UC diagnosis for at least 3 months, confirmed by standard diagnostic evaluations including clinical, biochemical, and endoscopic studies
•If age 17 years or younger, a PUCAI score of 10-60
•A partial Mayo score of 3-6
•If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 14 days before entry into study
•If on 5-Aminosalicylate, dose must be stable with following parameters:
•28 days on oral medication
•28 days on or off rectal medication
•If on background immunosuppressive treatment the dose must be stable with the following parameters:
•56 days (8 weeks) for Immunomodulators (methotrexate, 6-MP, Azathioprine)

Exclusion Criteria

•Expectation to increase corticosteroids and/or immunosuppressive treatment
•Presence of bowel stricture
•History of intra-abdominal or perirectal abscess
•Disease limited to only rectum (ulcerative proctitis)
•Active treatment with antibiotics
•Presence of active intestinal infection or documented infection by stool PCR or culture analysis in the previous 6 weeks
•Continuous treatment with an anticholinergic medication, including over the counter medications (See appendix)
•Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
•Current tobacco or nicotine user including nicotine patches, gum and vaping (to limit potential confounding effects of exposure to nicotine)
•Bowel resection surgery within past 90 days prior to study enrollment, or planned surgery within the course of the study