Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System
研究概览
简要总结
The aim of this study is to evaluate the potential improvement in colonoscopy procedure's outcomes when using the Pure-Vu System in hospitalized patients who are indicated for colonoscopy procedure.
详细描述
This multi-center, prospective, single arm study will include up to 100 patients (20-40 patients per site), aimed at evaluating the performance of the Pure-Vu System in cleansing hospitalized patients' colon who are indicated for standard colonoscopy procedure.
Subjects will be enrolled at up to 4 clinical sites in the United States and Europe. Subjects who meet the eligibility criteria will be prescribed a standard bowel preparation bowel preparation regimen including diet restrictions and oral bowel preparation.
Following the bowel preparation, the patient will undergo colonoscopy with the Pure-Vu system.
In case of inadequate bowel preparation, as per the nurse report and / or BBPS < 2, in at least one of the colon segments, prior Pure-Vu use, the physician will complete a questionnaire on the patient's management standard of care assuming the absence of Pure-Vu.
Follow-up will be conducted at 48 hours (± 48 hours) post procedure.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients who are indicated for a screening, diagnostic, surveillance or therapeutic colonoscopy
- •Patients' age > 22 years
- •Patient has signed the informed consent
排除标准
- •Patients with known Inflammatory Bowel Disease and / or active Colitis
- •Patients with active diverticulitis
- •Patients with known or detected (during colonoscopy) bowel obstruction
- •Patients with BMI ≤ 18
- •Patients with ascites Child Pugh C
- •Patients who are 30 days post-transplant
- •Patients treated with Peritoneal dialysis
- •Patients under active IV inotropic medications
- •Patients with LVAD
- •Patients who have active anticoagulant medications (excluding aspirin) or dual antiplatelet therapy in their system prior to the procedure. (Note: to avoid exclusion therapy should be discontinued 48 hours or greater prior to the procedure based on discretion of physician)
- •Subjects with known coagulation disorder (INR ≥ 2 or platelets <50,000)
- •Subjects with hemodynamic instability.
- •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
结局指标
主要结局
The Rate of Adequate Cleansing Level Before and After the Use of the Pure-Vu System
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 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) summed for the maximum score of 9 (0= dirtiest and 9= pristine). 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