NCT05662059招募中不适用
Investigating the Safety and Efficacy of Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) in Ulcerative Colitis (UC) in Pediatric and Young Adult Populations
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Clinical Remission
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blinded
入排标准
- 年龄范围
- 10 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •112 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
排除标准
- •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
- •Inability to comply with study and follow-up procedures
- •Individuals with prior medical history of significant arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, sick sinus syndrome, and AV blocks
- •Individuals with existing skin lesions on the left ear
结局指标
主要结局
Clinical Remission
时间窗: 12 weeks
Remission rate in treatment vs sham, assessed by a 0 or 1 point score in the Partial Mayo at week 12
次要结局
- Clinical Responder(12 weeks)
研究者
研究点 (2)
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