Ulcerative Colitis
Conditions
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.
Interventions
DEVICERAVANS
Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation
DEVICERAVANS-sham
RAVANS sham device
Sponsors
Cala Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blinded
Intervention model description
Sham-Controlled
Eligibility
Sex/Gender
ALL
Age
10 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
1. Age 10-39 years 2. UC diagnosis for at least 3 months, confirmed by standard diagnostic evaluations including clinical, biochemical, and endoscopic studies 3. If age 17 years or younger, a PUCAI score of 10-60 4. A partial Mayo score of 3-6 5. If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 14 days before entry into study 6. If on 5-Aminosalicylate, dose must be stable with following parameters: * 28 days on oral medication * 28 days on or off rectal medication 7. If on background immunosuppressive treatment the dose must be stable with the following parameters: * 56 days (8 weeks) for Immunomodulators (methotrexate, 6-MP, Azathioprine) * 112 days (16 weeks) for Infliximab, Adalimumab, Vedolizumab, Ustekinumab, other biologic, tofacitinib, upadacitinib, ozanimod 8. Able and willing to give written informed consent and comply with the requirements of the study protocol. 9. The earbud electrode must fit properly in the prospective subject's left ear 10. Fecal calprotectin of ≥150 during screening period
Exclusion criteria
1. Expectation to increase corticosteroids and/or immunosuppressive treatment 2. Presence of bowel stricture 3. History of intra-abdominal or perirectal abscess 4. Disease limited to only rectum (ulcerative proctitis) 5. Active treatment with antibiotics 6. Presence of active intestinal infection or documented infection by stool PCR or culture analysis in the previous 6 weeks 7. Continuous treatment with an anticholinergic medication, including over the counter medications (See appendix) 8. Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators. 9. Current tobacco or nicotine user including nicotine patches, gum and vaping (to limit potential confounding effects of exposure to nicotine) 10. Bowel resection surgery within past 90 days prior to study enrollment, or planned surgery within the course of the study 11. Any planned surgical procedure requiring general anesthesia within the course of the study 12. Participation in any other Investigational drug and/or treatment currently or planned during the length of the study 13. Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention 14. Pregnancy or Lactation 15. Comorbid disease with high likelihood of requiring corticosteroid use 16. Inability to comply with study and follow-up procedures 17. Individuals with prior medical history of significant arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, sick sinus syndrome, and AV blocks 18. Individuals with existing skin lesions on the left ear
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Remission | 12 weeks | Remission rate in treatment vs sham, assessed by a 0 or 1 point score in the Partial Mayo at week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Responder | 12 weeks | Responder rate in treatment vs sham, assessed by greater than or equal to a 2 point reduction in the Partial Mayo score at week 12 |
Countries
United States
Contacts
Primary ContactJillian Charyn
Backup ContactBenjamin Sahn, MD
Outcome results
None listed