NCT02372552已完成不适用
Clinical Evaluation of the Safety and Performance of Microwave Coagulation by the CROMA Electrosurgical System During Resection of Complex Colorectal Polyps
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pre-coagulation of visible blood vessels and treatment of actively bleeding vessels, ≤1mm in diameter.
研究概览
简要总结
This is a single centre, prospective, non-randomised pivotal clinical investigation to be undertaken at St Mark's Hospital, Harrow, UK.
详细描述
The study will recruit 30 patients undergoing endoscopic resection of complex colorectal polyps and be used to demonstrate safety and performance of the CROMA Electrosurgical System microwave coagulation modality. Study data will complement existing data to support a CE marking application for the CROMA Electrosurgical System (combined RF and microwave modalities).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, at least 18 years of age;
- •After standard clinical work-up a benign appearing lower bowel lesion >2cm in diameter;
- •Patient or authorised representative able to comprehend and sign the Informed Consent prior to enrolment in the study.
排除标准
- •Aged <18 years of age;
- •Pregnant or lactating females;
- •Lower bowel lesions <2cm in diameter;
- •Patients receiving regular systemic steroids;
- •Patients who are immuno-compromised (either acquired or congenital);
- •Patients with a known coagulopathy (either acquired or congenital);
- •Patients on anti-platelet therapy at the time of the procedure, apart from low dose (75mg) aspirin alone;
- •Concurrent participation in another experimental intervention or drug study;
- •Unwilling or unable to provide informed consent.
结局指标
主要结局
Pre-coagulation of visible blood vessels and treatment of actively bleeding vessels, ≤1mm in diameter.
时间窗: Peri-operative
Performance will be assessed on the basis of number of vessels successfully coagulated.
次要结局
- Post-procedural complications(28 weeks)
- Clinical outcome(28 weeks)
- Safety: assessed using reported Adverse Events(28 weeks)
- Intra-operative complications(Intra-operative)
研究者
研究点 (2)
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