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

NCT05662059 | Unknown FDA Device

• 1 other identifier: IBD-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Clinical Remission

  Remission rate in treatment vs sham, assessed by a 0 or 1 point score in the Partial Mayo at week 12

  12 weeks

Secondary Outcomes (1)

• Clinical Responder

  12 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

Two therapy sessions (active stimulation) per day for 12 weeks with Treatment device

Device: RAVANS

Sham

SHAM COMPARATOR

Two therapy sessions per day for 12 weeks with Sham device (no active stimulation)

Device: RAVANS-sham

Interventions

RAVANS DEVICE

Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation

Treatment

RAVANS-sham DEVICE

RAVANS sham device

Sham

Eligibility Criteria

• Age: 10 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• days on oral medication
• days on or off rectal medication
• If on background immunosuppressive treatment the dose must be stable with the following parameters:
• days (8 weeks) for Immunomodulators (methotrexate, 6-MP, Azathioprine)
• days (16 weeks) for Infliximab, Adalimumab, Vedolizumab, Ustekinumab, other biologic, tofacitinib, upadacitinib, ozanimod
• Able and willing to give written informed consent and comply with the requirements of the study protocol.
• The earbud electrode must fit properly in the prospective subject's left ear
• Fecal calprotectin of ≥150 during screening period

You may not qualify if:

• 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
• Any planned surgical procedure requiring general anesthesia within the course of the study
• Participation in any other Investigational drug and/or treatment currently or planned during the length of the study
• Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention
• Pregnancy or Lactation
• Comorbid disease with high likelihood of requiring corticosteroid use

Sponsors & Collaborators

• Cala Health, Inc.: lead

Study Sites (1)

Feinstein Institute for Medical Research at Northwell Health

Lake Success, New York, 11042, United States

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Jillian Charyn

CONTACT

516-472-3691; jcharyn@northwell.edu

Benjamin Sahn, MD

CONTACT

516-472-3650; Bsahn@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sham-Controlled

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 22, 2022
• Study Start: January 12, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

US (1)