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
- 47
- 主要终点
- The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem
研究概览
简要总结
The purpose of this study is evaluate the Motus GI Colon Cleansing system performance.
详细描述
Subjects indicate for colonoscopy procedure undergo a limited bowel preparation including 20 mg Bisacodyl (4*4 tables of 5 mg each) in split dose undergo standard colonoscopy with MCS.
following the procedure 2 follow-up call were conducted at 48 hours and 14 days after to the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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 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
- •Sever Liver insufficiency
- •Contraindication for "colonoscopy" anesthesia \ sedation \ prep agent pregnancy
- •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
Motus CleanC System
Colonoscopy with Motus CleanC Syetem - Device Rev 2.0 ,enrolled under protocol Rev 3.0
干预措施: Motus Cleansing System (Device)
Motus Cleansing System Rev 2.5
Colonoscopy with MCS Rev 2.5,enrolled under protocol Rev 4.0
干预措施: Motus Cleansing System (Device)
Motus Cleansing System Rev 3.0
Colonoscopy with MCS Rev 3.0,enrolled under protocol Rev 5.0
干预措施: Motus Cleansing System (Device)
结局指标
主要结局
The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem
时间窗: Following the colonoscopic procedure- Up to 24 hours.
The number of subjects had adequate bowel preparation after the use of Motus Cleansing System (i.e., all colon segments have BBPS\>=2) . Each colon segment was graded by using the Boston Bowel Preparation Score index before ( at baseline) and after the cleansing of the bowel by using the Motus Cleansing System.
次要结局
未报告次要终点