Optimizing the Preparation Regime Prior to Colonoscopy Procedure With Pure-Vu System
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- rate of adequate cleansing level
研究概览
简要总结
The primary objective of this multicenter, prospective, randomized study is to evaluate the performance of Pure-Vu System in cleansing patients' colon who are indicated for a colonoscopy procedure using one of two different reduce bowel preparation regimes.in addition, the cecum intubation rate, time to cecum, total procedure time, and adverse event will be evaluated.
详细描述
This multicenter, prospective, randomized study will include up to 100 patients (30 patients per site and 15 patients per study arm), aimed at evaluating the performance of Pure-Vu System in cleansing patients' colon who are indicated for colonoscopy procedure using one of two different preparation regimes as detailed below.
Subjects will be enrolled at up to 10 clinical sites in the United States. Subjects who meet the eligibility criteria will be randomly allocated to a given study arm and will be required to follow a specific bowel preparation instruction along with a specific prep agent (Bowel preparation instructions for morning and afternoon procedures are provided in appendix B1 and B2, respectively), as per study arm allocation, starting 5 days prior to the colonoscopy with Pure-Vu. Patients will be asked to record and provide their diet and bowel movements in the provided diary log at time of their scheduled colonoscopy (Diary log is provided in appendix D).
In addition patient will be ask to complete a satisfaction questionnaire include feedback on the procedure and on specific aspects related to the preparation regime.
Following the procedure a telephone follow-up will be conducted at 48 hours (± 48 hours) post Pure-Vu procedure to assess patient well-being and capture any adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
盲法说明
No blinding is applicable in this study .
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects scheduled for colonoscopy procedure
- •Subjects in the age range of 22-75 years inclusive
- •Subject is willing and able to participate in the study procedures and to understand and sign the informed consent.
排除标准
- •Patients with active Inflammatory Bowel Disease
- •Patients with known diverticulitis disease or with prior incomplete colonoscopy due to diverticular disease
- •Patients with known bowel obstruction
- •Patient with chronic constipation
- •History of prior surgery to colon and/or rectum
- •ASA (Physical status classification system) ≥ III
- •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)
- •Patients taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy
- •Patients with known coagulation disorder (INR >1.5).
- •Pregnancy (as stated by patient) or breast feeding
- •Patients with altered mental status/inability to provide informed consent
研究组 & 干预措施
10mg Magnesium citrate
subjects will be required to follow a specific bowel preparation instruction consisting of dietary restrictions (no dried fruit, seeds or nuts) starting 5 days prior to the colonoscopy, an low residue diet at the day before the procedure, followed by a split dose of 10 mg of Magnesium citrate, followed by colonoscopy procedure with Pure-Vu System
干预措施: Pure-Vu System (Device)
15mg Magnesium citrate
subjects will be required to follow a specific bowel preparation instruction consisting of dietary restrictions (no dried fruit, seeds or nuts) starting 5 days prior to the colonoscopy, an low residue diet at the day before the procedure, followed by a split dose of 15 mg of Magnesium citrate, followed by colonoscopy procedure with Pure-Vu System
干预措施: Pure-Vu System (Device)
结局指标
主要结局
rate of adequate cleansing level
时间窗: up to 2 hours
The rate of adequate cleansing level in each colon segment before and after use of Pure-Vu will be evaluated per study arm 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). BBPS\* scores will be rated by the colonoscopies, on the basis of three segment scores summed for maximum score of 9, where: * 0 = unprepared * 9 = completely clean (in completed to Cecum procedures) An adequate cleansing procedure will be considered when all the colon segments will be graded as 2 or above.
次要结局
未报告次要终点