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
- 试验地点
- 3
- 主要终点
- Performance of MCS in Cleansing a Poorly Prepared Colon.
研究概览
简要总结
The study is multi-center study ,planned as a single arm, open trial, aimed at evaluating the performance and safety of a colon cleansing device during a colonoscopy procedure in a poorly prepared colons.
详细描述
Total of 47 subjects are planned to be enrolled at 3 clinical sites (1 in Germany and 2 in the Netherlands).
Subjects who meet the eligibility criteria will be screened for study participation at a baseline visit(visit 1). Subject who is eligible to the study will required to follow a specific reduced preparation instruction starting 2 days prior to the colonoscopy with the Motus Cleansing System (MCS) procedure.
Following the procedure a telephone follow-up will be conducted at 48 hours (± 24 hours) and 14 days (± 3 days) post MCS procedure to assess patient well-being and capture any Adverse Events (AE).
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 BodyMass 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) or dual antiplatelet therapy
- •Subjects with known coagulation disorder (INR >1.5).
- •Subjects treated with H2 receptor antagonists or proton pump inhibitors within the 72 hours prior to consuming the Bisacodyl
- •Subjects with active, ongoing lower GI bleeding with hemodynamic instability.
- •Subjects with known Mega Colon
- •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
研究组 & 干预措施
Colonoscopy with MCS
Standard colonoscopy procedure with Motus Cleansing System
干预措施: Motus Cleansing System (MCS) (Device)
结局指标
主要结局
Performance of MCS in Cleansing a Poorly Prepared Colon.
时间窗: Up to 2 hours
The rate of adequate cleansing level per subject will be evaluated by the Boston Bowel Preparation (BBPS) scoring index before and post the cleansing operation.
次要结局
未报告次要终点