Evaluation of the Motus Gl CleanUp System During Screening Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System
研究概览
简要总结
Motus Gl is developing a single-use device that attaches to a standard colonoscope, thereby integrating colon cleansing, screening and treatment into one procedure.
The device creates turbulence within the colon using water jets. The colon's fecal fluids are evacuated by the system.
详细描述
63 eligible subjects who are allocated for a diagnostic screening colonoscopy were enrolled in the study. The assignment of the level of the bowel preparation agent was according to the physician decision. Following preparation, enrolled subjects were intubated and cleansed using a standard colonoscope with the Motus GI CleanUp device attached to it. At the end of the procedure, subjects were followed through discharge and at 48 hours post procedure for occurrence of adverse events.
40 subjects were enrolled under protocol Rev 1.0 used Motus GI CleanUp System Rev 1.0 31 subjects were enrolled under protocol Rev 2 used Motus GI CleanUp System Rev 1.5, due to improvement made to the study device including the following:
- One head that irrigates and evacuates instead of two heads
- Elimination of the grinding mechanism and the motor to reduce the pipes' diameters while keeping the same flow rate.
- System adjustment to the above changes including updated software version.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 69 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 50-69 years
- •Subjects who are considered for routine screening colonoscopy
- •Subjects with BMI within the range of 18.5-30
- •Subject is willing to sign informed consent form
排除标准
- •History of G diseases or history of Colorectal cancer (personal or family)
- •Previous major abdominal surgeries
- •Medical status ASA grater or equal to 3
- •Acute Gl symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (lBD).
- •Patients taking anticoagulants (e.g., Coumadin, Heparin, Clopidrogrel)
- •Life-threatening condition
- •Subjects who are unable or unwilling to cooperate with study procedures
- •Severe Diverticula
结局指标
主要结局
Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System
时间窗: during colonoscopy procedure after cleansing with CleanUp System
Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). average of all colon segments BBPS score after the use of MotusGI CleanUp System
次要结局
未报告次要终点