Randomized Controlled Study Comparing Colon Evaluation With The Pure-Vu System To A Standard Colonoscopy In Patients Who Are High Risk For Inadequate Bowel Preparation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- rate of adequate cleansing level after using the Pure-Vu System as compare to sandard of care colonoscopy procedure
研究概览
简要总结
The primary objective of this multi-center, prospective, randomized controlled trial is to evaluate the bowel cleansing after Pure-Vu use in outpatient subjects at high risk for inadequate colon preparation as compare to standard of care.
详细描述
Total of 88 subjects (44 per arm) at high risk for inadequate colon preparation will be randomized and undergo procedure either in the Control arm (standard of care) or with the Pure-Vu System.
Subjects will be enrolled at up to 4 clinical sites in the United States.
primary endpoint- A comparison between the two study arms (i.e., Pure-Vu vs. standard colonoscopy) of the rate of overall cleansing as well as cleansing per segment will be evaluated by the BBPS scoring index (Bowel preparation adequacy defined as BBPS >2 in each segment)
The following secondary endpoints will be determined:
- Assess the willingness of consented subjects to pay for Pure-Vu prior to colonoscopy
- Colonoscopy procedural measures for Intervention and Control arms
- Endoscopists' experience
- Safety assessment for all subjects on the day of procedure per endoscopist
- Post-colonoscopy patient experience and safety check with scripted phone call 1-3 days after colonoscopy
- Assess the willingness of consented subjects to pay for the Pure-Vu System 1-3 days after colonoscopy
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
- Single (Participant)
盲法说明
The Colonoscope will be prepared as per normal routine and the research assistant will cover the colonoscope before the patient enters the endoscopy room to keep him/her blinded to the study arm. This is uncovered once the patient is sedated.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults > age 22
- •Elective outpatient colonoscopy by participating gastroenterologist
- •Stool clarity grade 1-3 at presentation for colonoscopy
排除标准
- •Not competent to consent
- •Bleeding disorder - known or suspected
- •Hereditary Gastrointestinal Cancer syndrome
- •Known PT INR > 1.5
- •Know elevated PTT
- •Anti-platelet agent or anticoagulant (other than aspirin or nonsteroidal agent) which has not been stopped for the colonoscopy
- •Known platelet count < 50,000
- •Known absolute neutrophil count < 1,000
- •History of surgical colon resection
- •Pre-colonoscopy intent to enter terminal ileum
- •Prior incomplete colonoscopy due to technical & non-bowel preparation related reasons
- •Regular use of non-topical steroid
- •Prisoner or institutionalized for any reason
- •Psychiatric illness greater than mild
- •Colonoscopy without anesthesia administered (MAC) sedation
- •Diverticulitis
- •Active inflammatory bowel disease (Crohn's, Ulcerative Colitis, or Indeterminate)
- •Known or suspected colon stricture
研究组 & 干预措施
standard Colonoscopy
Control arm
Colonoscopy procedure using standard flushing and suctioning - standard of care
Pure-Vu System
Intervention - Colonoscopy procedure using Pure-Vu System
干预措施: Pure-Vu System (Device)
结局指标
主要结局
rate of adequate cleansing level after using the Pure-Vu System as compare to sandard of care colonoscopy procedure
时间窗: Up to 2 hours
A comparison between the two study arms (i.e., Pure-Vu vs. standard colonoscopy) of the rate of overall cleansing as well as cleansing per segment will be evaluated by the BBPS scoring index (Bowel preparation adequacy defined as BBPS \>2 in each segment)
次要结局
未报告次要终点