NCT07311590尚未招募不适用
A First-in-human Clinical Trial Evaluating the Feasibility of Performing Colonoscopic Polypectomy With a Novel Colonic Intraluminal Endoscopic Support Structure (CIESS) In-situ
JurongHealth0 个研究点目标入组 4 人开始时间: 2025年12月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4
- 主要终点
- Ability to deploying CIESS in a single attempt
研究概览
简要总结
The aim of the first-in-human clinical trial is to evaluate the feasibility of performing colonoscopic polypectomy with a novel colonic intraluminal endoscopic support structure (CIESS) in-situ
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive fecal occult blood test
- •only patients with left-sided colonic polyp during colonoscopy will be included into the study eventually
排除标准
- •History of malignancy, gastrointestinal tract/ abdominal surgery, diverticular disease, abdominal/ pelvic radiation
- •Pregnancy patient
- •cognitively impaired patients
- •Patients on blood thinners or anticoagulants
- •ASA III / ASA IV
结局指标
主要结局
Ability to deploying CIESS in a single attempt
时间窗: From enrollment to end of treatment at 4 weeks
Primary outcome measure is whether the CIESS can be deployed successfully in a single attempt - this is a measure of the feasibility of deploying the CIESS during colonoscopy. This outcome will be recorded as "successfully deployed in a single attempt or unsuccessfully deployed in a single attempt"
次要结局
未报告次要终点
研究者
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