Evaluation of the Performance of the "CleanC" System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 )
研究概览
简要总结
The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.
详细描述
The study aim to evaluate the post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS).
Each subject was required to follow a bowel preparation regimen including split dose of 2 tablets of 5mg Bysacodyle followed by a colonoscopy procedure with the tested device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects in the age range of 18-75 years
- •Subjects with BMI within the range of 18.5-35
- •Subject is willing to sign informed consent form
排除标准
- •Active or severe inflammatory bowel disease (IBD)
- •Subjects with severe diverticulitis \ diverticular disease (known or detected)
- •Known or detected colonic stenosis
- •Known or detected bowel obstruction
- •History of prior colon surgery
- •ASA≥IV (sever systemic disease)
- •Sever Renal insufficiency (Creatinine≥1.5mg%)
- •Sever Liver insufficiency (ALT/AST≥2UNL)
- •Contraindication for "colonoscopy" anesthesia \ sedation \ prep agent
- •Subjects with altered mental status/inability to provide informed consent
- •Subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly
研究组 & 干预措施
CleanC
Standard colonoscopy procedure using the CleanC system
干预措施: CleanC system (Device)
结局指标
主要结局
Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 )
时间窗: During the colonoscopy procedure withdrawal phase (10 min in average)
Scale ranges- Min-0, Max-3 where: 0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. 1. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid. 2. = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well. 3. = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. The wording of the scale was finalized after incorporating feedback from three colleagues experienced in colonoscopy.
Safety as Measured by Number of Serious Adverse Events and Major Complications.
时间窗: Max of 9 days
次要结局
- Percentage of Participants in Whom the Cecum Was Reached(During the colonoscopy procedure)