NCT04854473已完成不适用
Data Collection Study - Recording Electro-physiological Signals From Intact (to be Resected, Pathological) and Ischemic Bowel Tissue During Open Colonic Surgery.
Exero Medical Ltd.2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2020年6月4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
- 5
- 试验地点
- 2
- 主要终点
- Functionality of signal measurement
研究概览
简要总结
The study is conducted to record continuous electrophysiological signals from intact and ischemic bowel tissue during colonic resection surgery, in order to train the Exero Medical Leak Detection System classification algorithm on detection of ischemic conditions.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Patient is scheduled for open colonic resection, (right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection or subtotal colectomy) surgery.
- •Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out.
排除标准
- •Subject has gastroparesis.
- •Subject has significant multisystem (autonomic) diseases.
- •Subject has a body mass Index greater than 35 kg/m2
- •Subject has an autoimmune disorder requiring therapy in the preceding 2 years.
- •Subject has significant cardiac arrhythmia or ectopy.
- •Obstructing lesion and pre obstruction bowel dilatation
- •Subject has an existing implanted electrical stimulator (e.g., pacemaker.
- •Subject requires chronic anticoagulant therapy
- •Subject is currently enrolled in other potentially confounding research.
- •Current alcohol abuse
- •Subject poses a significant general anesthesia risk
- •Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
结局指标
主要结局
Functionality of signal measurement
时间窗: 10 minutes
Baseline data collected from the intended bowel segment to be resected, prior to tissue manipulation, is compared to the data recorded after the ischemia induced by the resection procedure.
次要结局
- Occurrence of adverse events(10 minutes)
研究者
研究点 (2)
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