Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 22
- 主要终点
- Assess that the use of the device meet the established functional requiremnt of allowing the removal of polyps
研究概览
简要总结
The aim of the clinical trial is to investigate whether the use of a new multichannel endoscopic transanal access device (named UNI-VEC) is safe and effective in the resection of a rectal polyp or tumor that sits in the distal part of the colon (up to about 20 cm from the anal margin). This is the first study to test the device in humans, after proving its good performance in preclinical development (preclinical development has included functional laboratory tests and an animal trial).
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
- •All polyps included in the Paris Classification (Polypoid (0-I): Sessile type (Is), Pedunculated type (Ip), Non-polypoid (0-II, III): Raised type (IIa), Flat type (IIb), Depressed type (IIc), Excavated type (III))
- •Lesions located from the anal margin to about 20 cm.
- •Extent of at least 2 cm² (polyps 2 cm in diameter or areas of ERM or ESD 2 x 2 cm).
- •Well or moderately differentiated tumours. T1: Tumours confined to the mucosa (Tis) and submucosa (T1).
- •No positive lymph nodes.
- •No lymphatic, vascular or perineural invasion.
排除标准
- •Are considered vulnerable subjects.
- •They suffer from hematological diseases with altered coagulation of their own or pharmacologically induced coagulation disorders (the use of acetylsalicylic acid (ASA) in doses of 150 mg/day is permitted).
- •Have rectal lesions that lie above the pectineal line or extend into the anal canal.
- •Local or distant metastasis.
- •Have a score of more than 2 points on the Wexner faecal incontinence scale.
结局指标
主要结局
Assess that the use of the device meet the established functional requiremnt of allowing the removal of polyps
时间窗: During the procedure
The device must allow the removal of polyps with a minimum size of 2 cm (maximum diameter of the removed polyp measured in mm) in the rectum.
次要结局
- Rate of anorectal hemorrhagic events(During the intervention and 1 week after the intervention.)
- Rate of injuries to the anorectal canal and perianal region(During the intervention and 1 week after the intervention.)
- Assessment of anorectal continence(At 7 and 30 days after the procedure. If anorectal incontinence persists at 30 days: follow-up at 2 months. If anorectal incontinence persists: follow-up at 6 months.)