NCT05414955已完成不适用
Boom-IBD Clinical Trial
Boomerang Medical14 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 14
- 主要终点
- Disease Activity Index
研究概览
简要总结
Feasibility study of neuromodulation in patients with IBD.
详细描述
The study will evaluate responses of patients with IBD treated with neuromodulation at various intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria:
- •Male or female
- •18 to 75 years of age
- •Diagnosed with Crohn's Disease or ulcerative colitis
- •Ability and willingness to consent to participate by signing the informed consent form
- •Ability to comply with the protocol and willingness to comply with all follow-up requirements
- •Still have part or all of their colon
排除标准
- •(The subject must not meet ANY of the following criteria):
- •Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study
- •Any psychiatric or personality disorder at the discretion of the study investigator
- •Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)
- •Active clostridium difficile infection of the colon
- •Active cytomegalovirus (CMV) infection of the colon
- •Evidence of colonic perforation
- •Fulminant colitis requiring emergency surgery
- •Microscopic, ischemic or infectious colitis
- •Unresected neoplasia of the colon
- •Colonic stricture unable to pass a colonoscope
- •History of cancer including melanoma (except for localized skin cancers) within 2 years
- •Participation in another clinical trial within the past 30 days of device implant
- •Investigational drug for the treatment of inflammatory bowel disease within 6 months of device implant
- •Inability to operate the patient programmer
结局指标
主要结局
Disease Activity Index
时间窗: up to 1 year
CDAI (Crohn's Disease Activity Index Score) or MAYO Score (ulcerative colitis)
次要结局
未报告次要终点
研究者
研究点 (14)
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