NCT00164177已完成4 期
A Preliminary Evaluation Of The Efficacy Of HalfLYTELY® For Bowel Cleansing Before Virtual Colonoscopy (VC) and Conventional Colonoscopy (CC).
Braintree Laboratories1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2004年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Efficacy of the preparation to produce a degree of fecal matter and residual liquid that would not interfere with VC or CC.
研究概览
简要总结
To evaluate the efficacy of standard HalfLYTELY® as a bowel cleansing preparation for adult patients undergoing virtual colonoscopy (VC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
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
- •Male or female outpatients who are undergoing colonoscopy for routinely accepted indications, Evaluation of BE results, GI bleeding, Anemia of unknown etiology, Neoplastic disease surveillance, Endosonography, Inflammatory bowel disease (except as noted below), Unknown diarrhea etiology, Prior Polypectomy, Laser therapy, Foreign body removal and decompression (except as noted below).
- •18 years of age or older.
- •Otherwise in good health, as determined by physical exam and medical history.
- •If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, or vasectomized spouse)
- •Subject has read and signed the written informed consent document prior to study participation
排除标准
- •Subjects with known or suspected bowel perforation or obstruction, inflammatory bowel disease, ileus, acute alimentary tract surgery, significant gastroparesis or gastric outlet obstruction, appendicitis, gastric retention, toxic colitis, toxic megacolon or rectal bleeding.
- •Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
- •Subjects with uncontrolled cardiovascular disease
- •Subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.
- •Subjects who have participated in an investigational clinical surgical, drug or device study within the past 30 days.
- •Subjects who are pregnant or lactating.
- •Subjects who are allergic to Polyethyleneglycol.
- •Subjects receiving non-study laxatives, antacids and prokinetic agents during the study.
结局指标
主要结局
Efficacy of the preparation to produce a degree of fecal matter and residual liquid that would not interfere with VC or CC.
次要结局
- Incidence of adverse events.
研究者
研究点 (1)
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