NCT01838980已完成不适用
Evaluation of the Motus GI CleanUp System During Screening
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Mean of All Subjects Colon Segments BBPS>=2
研究概览
简要总结
Motus GI 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.
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
- 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 GI diseases or history of Colorectal cancer (personal or family)
- •Previous major abdominal surgeries
- •Medical status ASA grater or equal to 3
- •Acute GI symptoms, such as bleeding, unexplained weight loss, inflammatory bowel disease (IBD).
- •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 of All Subjects Colon Segments BBPS>=2
时间窗: Following the colonoscopic procedure- Up to 24 hours.
Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). Summing all colon segments BBPS score of all participants dividing in the number of segments is expected to be \>=2.
次要结局
未报告次要终点
研究者
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