Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 13
- 主要终点
- Capsule excretion rate
研究概览
简要总结
The purpose of the study is to test the effect of a bowel preparation and boosts regimen on PillCam® procedure, colon cleanliness and capsule excretion time.
详细描述
Interim analysis will be done after 20 subjects are enrolled in order to assess the 1st arm. Following the analysis of the first phase results, and per need, 30 more subjects may be enrolled under a different regimen (2nd arm). Second Interim analysis will be done in order to assess the 2nd phase results. Following the analysis of the 2nd phase results, and per need, up to 30 additional subjects may be enrolled under a third regimen (3rd arm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is between 50 - 75 years of age.
- •Subject received an explanation about the nature of the study and agrees to provide written informed consent.
排除标准
- •Subject has dysphagia or any swallowing disorder
- •Subject has congestive heart failure
- •Subject has Diabetes type I.
- •Subject has had prior abdominal surgery other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator
- •Subject has a cardiac pacemaker or other implanted electro medical device.
- •Subject has any allergy or other known contraindication to the medications used in the study
- •Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
- •Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy.
- •Subject with gastrointestinal motility disorders
- •Subject has known delayed gastric emptying
- •Subject has any condition, which precludes compliance with study and/or device instructions.
- •Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
- •Subject suffers from life threatening conditions
- •Subject currently participating in another clinical study
研究组 & 干预措施
MgC boosts
Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects will be administered MgC boosts.
干预措施: PillCam® COLON 2 procedure using MgC boosts (Other)
Suprep boosts
Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects will be administered Suprep boosts
干预措施: PillCam® COLON 2 procedure using Suprep boosts (Other)
Suprep boosts - Reduced dose
Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects will be administered a reduced dose of Suprep boosts
干预措施: PillCam® COLON 2 procedure using reduced dose of Suprep boosts (Other)
结局指标
主要结局
Capsule excretion rate
时间窗: 10 hours post capsule ingestion
次要结局
- Distribution of PillCam® COLON 2 excretion times(Up to 12 hours and at least 12 hours)