Feasibility and Safety of MiWEndo-assisted Colonoscopy:Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 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 a small group of patients to assess the preliminary safety of its use 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 animal model (pig).
详细描述
This study is designed as a single-center prospective, non-comparative, first in human pilot safety and feasibility study with few 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 aim is to assess the clinical safety of the device and the feasibility of its use in assisted colonoscopy. Relevant claims to verify in this study are that the device 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, 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 a subsequent clinical investigation (pivotal study).
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
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women older than 50 years referred for a diagnostic or surveillance colonoscopy and having signed the Informed Consent Form.
排除标准
- •Patients at a high risk of having major complications as perforation or hemorrhage or in whom the possibility of performing a complete colonoscopy is reduced, including: patients with known colonic strictures, total colectomy, acute diverticulitis, inflammatory bowel disease, suspected or proven lower gastrointestinal bleeding, non-correctable coagulopathy or anticoagulant/clopidogrel therapy during procedure, inadequate bowel cleansing or previous incomplete colonoscopy.
- •ASA-IV patients
- •Urgent colonoscopy
结局指标
主要结局
Number of mural injuries
时间窗: During the procedure
To assess the safety of MiWEndo colonoscopy according to the Sydney classification for deep mural injuries (DMI)
Rate of cecal intubation
时间窗: During the procedure
To assess the feasibility of performing a complete colonoscopy using the MiWEndo System. This parameter will be measured as complete colonoscopy (yes/no).
Number of incidents and adverse events
时间窗: During the procedure and up to 2 weeks after
To assess the safety of MiWEndo colonoscopy using the lexicon proposed by the American Society of Gastrointestinal Endoscopy (ASGE).
Length of colon explored
时间窗: During the procedure
In case cecum could not be reached, the distance will be measured (in cm).
次要结局
- Total time for completing the procedure(Immediately after the procedure)
- Time for reaching the cecum (or maximum explored colon length)(During the procedure)
- Perception of difficulty(Immediately after the procedure)
- Patients' comfort(Immediately after the procedure and 2 weeks after)