Safety Evaluation of Bowel Cleansing Regimen for PillCam® COLON 2 Capsule Endoscopy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- To evaluate the safety of a bowel preparation regimen comprised of Sulfate free Polyethylene glycol electrolyte lavage solution (SF-PEG) plus SUPREP oral sulfate solution as a "booster", in adult subjects.
研究概览
简要总结
This study is designed to evaluate the safety of a preparation regimen for PillCam® Colon 2 Capsule Endoscopy.
详细描述
The preparation regimen used for the PillCam® Colon 2 procedure consists of several colon cleansing materials.
Different combinations of the above regimen were tested and evaluated for safety by monitoring of adverse events in multiple clinical studies, with more than 1000 subjects enrolled to date. No Serious Adverse Events related to the preparation were noted.
In this study, each subject will be required to undergo serum chemistry tests (blood tests) at several time points to evaluate the safety of the regimen.
No capsule ingestion is involved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 is healthy without any known disease, or any current symptoms of any disease or other abnormal condition.
- •Subject received an explanation about the nature of the study and agrees to provide written informed consent.
- •Subject has normal serum chemistry tests at baseline.
排除标准
- •Subject has any allergy or other known contraindication to the medications used in the study.
- •Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
- •Subject has Type 1 or Type II Diabetes.
- •Subject has any condition which precludes compliance with study 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.
- •Concurrent participation in another clinical trial using any investigational drug or device.
结局指标
主要结局
To evaluate the safety of a bowel preparation regimen comprised of Sulfate free Polyethylene glycol electrolyte lavage solution (SF-PEG) plus SUPREP oral sulfate solution as a "booster", in adult subjects.
时间窗: Latest blood test conducted (i.e. 24 hours after suppository or seven days after procedure)
Safety will be evaluated by number of Adverse Events and percentage of subjects with clinically siginifcant change in serum chemistry test.
次要结局
未报告次要终点