Performance and Safety of MiWEndo-assisted Colonoscopy: MiWEndo II (Pivotal Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of mural injuries.
研究概览
简要总结
The study involves the planned use of a new microwave-based device during colonoscopy procedures in 50 patients to assess the performance and safety of its use for detection of colorectal polyps and lack of normal clinical practice modification. The device is a final design version, which has been previously tested in several preclinical studies (including phantom studies, an ex vivo study with human tissues, and an in vivo study with porcine model) and in a pilot study in humans (NCT05477836)
详细描述
This study is designed as a single-center prospective, non-comparative study in 50 patients, whereby data will be subject to an analytical description, rather than to a statistical treatment (refer to Statistical design and analysis).
In this study the principal aims are to assess the performance and safety of the device for the detection of colorectal polyps when used as an accessory to colonoscopy. Relevant claims to verify in this study are that the device will detect in first instance polyps not detected initially with the endoscopic image and can be used without ADEs, without any change in the current clinical practice, as well as without any major difficulty by the endoscopist, neither in the preparation nor in the use of the device during exploration.
In addition, in the first phase of the study (n=15 patients), the study aims to gather real clinical data with the use of the device to optimise the processing software that will be key to demonstrate MiWEndo's performance on the second part of the study (n=35 patients).
Consequently, principal and secondary objectives of this investigation, are:
Principal objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •- Patients with a previously detected polyp in the rectum referred for resection.
- •These criteria will ensure the probability of finding polyps during the explorations.
- •All the patients will give written informed consent.
排除标准
- •Patients at a high risk of having major complications as perforation or hemorrhage, suspected or proven lower gastrointestinal bleeding, non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure, inadequate bowel cleansing.
- •ASA-IV patients.
- •Urgent colonoscopy.
研究组 & 干预措施
MiWEndo + colonoscope
All patients will be explored with MiWEndo as an accessory to colonoscopy
干预措施: MiWEndo System (Device)
结局指标
主要结局
Number of mural injuries.
时间窗: During the procedure and up to 2 weeks after.
Mural injuries related with the use of the MiWEndo.
Number of polyps
时间窗: During the procedure.
With MiWEndo assisted colonoscopy, detect at least one polyp before colonoscopy in 10% of patients.
Number of adverse events.
时间窗: During the procedure and up to 2 weeks after.
Number of adverse events related with the use of the MiWEndo using the lexicon proposed by the American Society of Gastrointestinal Endoscopy (ASGE) (Cotton PB et al. GIE 2010;71:446-54).
次要结局
- Number and size (adenomas and polyps).(During procedure.)
- True positives (TP), False positives (FP), False negatives (FN).(During procedure.)
- Patients' comfort.(Immediately after the procedure and 2 weeks after.)
- Perception of difficulty.(Immediately after the procedure.)