Evaluation of the PillCam Colon Capsule Endoscopy (PCCE) After Incomplete Colonoscopy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 74
- 试验地点
- 6
- 主要终点
- Evaluation of the efficacy of PillCam Colon2 to visualize the colon segment not reached by an incomplete standard colonoscopy
研究概览
简要总结
Purpose of study:
To evaluate the efficacy of PillCam Colon2 in subjects with an incomplete standard colonoscopy
Study design: 4 centers, prospective, cohort study Number of subjects: 74 subjects
Subject population: Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases and had an incomplete standard colonoscopy
Control group: None Procedure Duration: Approximately 10-12 hours Duration of Follow up: One week follow up Duration of study: 12 months
Primary objectives: Evaluation of the efficacy of PillCam Colon2 to visualize the colon segment not reached by an incomplete standard colonoscopy Evaluation of distribution of excretion of capsules over time
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is >/= 18 years
- •Subject is suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy.
- •Standard colonoscopy could not be performed completely in spite of adequate bowel cleansing and in the absence of a relevant colonic or rectal stenosis. Reasons for incomplete colonoscopy: adhesions, elongated colon, repeatedly forming loops, difficult procedure(time to reach the cecum >45 min), adverse reaction to sedation requiring termination of colonoscopy
排除标准
- •Subject has dysphagia or any swallowing disorder
- •Subject has severe congestive heart failure or renal insufficiency
- •Subject with high risk for capsule retention
- •Subject has a cardiac pacemakers or other implanted electromedical devices
- •Subject has any allergy or other contraindication to the medications used in the study
- •Subject is expected to undergo MRI examination 7 days after capsule ingestion Subject has any condition, which precludes compliance with study and/or device instructions.
- •Women who are pregnant or nursing at the time of screening and/or during the study period, or are of child bearing potential without medically acceptable methods of contraception
- •Subject suffers from life threatening conditions
- •Subject currently participating in another clinical study
- •Colonoscopy had been performed by a physician who has experience of <1000 complete colonoscopies
- •Exchange of the endoscope had been performed because complete colonoscopy was impossible with the standard endoscope
- •Time interval between incomplete colonoscopy and capsule endoscopy >30 days
结局指标
主要结局
Evaluation of the efficacy of PillCam Colon2 to visualize the colon segment not reached by an incomplete standard colonoscopy
时间窗: One week follow up
Study endpoint: Number of patients in whom capsule colonoscopy visualizes the complete segments missed by prior incomplete standard colonoscopy.
次要结局
未报告次要终点