Clinical Investigational Plan: Evaluation of the Performance of the Motus Cleansing System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of MCS
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 main objective of the study is to evaluate the performance of the Motus cleansing system used in conjunction with screening, diagnostic or surveillance colonoscopy
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 being considered for diagnostic, screening or surveillance colonoscopy
- •Subjects in the age range of 18-75 years inclusive
- •Subjects with Body Mass Index (BMI) within the range of 18.5-35 inclusive
- •Subject has signed the informed consent
排除标准
- •Subjects with known Inflammatory Bowel Disease
- •Subjects with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
- •Subjects with known or detected (during colonoscopy) bowel obstruction
- •History of prior surgery to colon and/or rectum
- •Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)
- •Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical history)
- •Subjects taking anticoagulants drugs (excluding aspirin) and dual anti-platelet therapy
- •Pregnancy (as stated by patient) or breast feeding
- •Subjects with altered mental status/inability to provide informed consent
- •Patients who have participated in another interventional clinical study in the last 2 months
结局指标
主要结局
Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of MCS
时间窗: Within 24 hours- During the colonoscopy procedure
The rating of the cleansing quality was evaluated by using the Boston Bowel Preparation Scale (BBPS), Segment score of 0-3 given to each of the 3 segments of the colon (Left side, Transverse and right side): Score 0- Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared. Score 1- A portion of the mucosa of the colon segment is seen, but other areas of the colon segment are not seen well due to staining, residual stool, and/or opaque liquid. Score 2- A minor amount of residual staining, small fragments of stool, and/or opaque liquid are visible, but the mucosa of the colon segment are seen well. Score 3-The entire mucosa of the colon segment is seen well with no residual staining, small fragments of stool, or opaque liquid. subject consider as having adequate cleaning if BBPS\>1 in all colon segments
次要结局
未报告次要终点