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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Two therapy sessions (active stimulation) per day for 12 weeks with Treatment device |
|
| Sham | Sham Comparator | Two therapy sessions per day for 12 weeks with Sham device (no active stimulation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAVANS | Device | Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Responder | 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 | 12 weeks |
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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:
If on background immunosuppressive treatment the dose must be stable with the following parameters:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jillian Charyn | Contact | 516-472-3691 | jcharyn@northwell.edu | |
| Benjamin Sahn, MD | Contact | 516-472-3650 | Bsahn@northwell.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Feinstein Institute for Medical Research at Northwell Health | Recruiting | Lake Success | New York | 11042 | United States |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Sham-Controlled
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Double-blinded
| RAVANS-sham |
| Device |
RAVANS sham device |
|
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |