Recruiting

RAVANS

Sponsor:

Cala Health, Inc.

Code:

NCT05662059

Conditions

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 10 - 39

Healthy Volunteers: Not accepted

Interventions

RAVANS

RAVANS-sham

Study Details

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

Study ID

NCT05662059

Start date

Jan 12, 2023

Status verified date

Mar, 2023

Completion date

Dec 30, 2023

Anticipated

Primary completion date

Dec 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 39

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Treatment

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

sham comparator: Sham

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

Interventions

RAVANS

Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation

RAVANS-sham

RAVANS sham device

Primary outcome measure

  • Clinical Remission [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

Feinstein Institute for Medical Research at Northwell Health

Recruiting

Lake Success, New York, United States, 11042

Contacts

Principal Investigator:

Benjamin Sahn, MD

More Information

Sponsor

Cala Health, Inc.

Last update posted

Mar 17, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cala Health, Inc. on 2023-03-17.