NCT00715325Unknown1 期
Evaluation of Safety and Efficacy of a New Colonoscope, ProtectiScope CS, to Diagnose Large Bowel Diseases
Stryker GI Ltd.0 个研究点目标入组 200 人开始时间: 2008年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 200
- 主要终点
- To determine the success rate in reaching within working distance of the Cecum with no complications.
研究概览
简要总结
The purpose of this study is to determine whether the ProtectiScope CS is capable to perform diagnostic and therapeutic colonoscopy.
详细描述
The ProtectiScope CS is a disposable-based colonoscope incorporating a miniature video camera,integral light source along with single-use sleeves and application Channels.
The ProtectiScope CS is intended to provide visualization and therapeutic access to the Lower Gastrointestinal Tract, in adult patient populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject between the ages of 18 and 80
- •Subject is indicated for screening colonoscopy
- •Subject is willing to sign informed consent form
排除标准
- •Subject is suspected, based on radiographic or other clinical grounds, of suffering from one or more of the following: full or partial colonic obstruction; acute abdomen; gross hematochezia; severely ulcerated colon; diverticulitis; severe diverticulosis; toxic megacolon.
- •Subject has active cardiac problems and history of heart failure, severe pulmonary diseases renal failure (creatinine >2) uncontrolled diabetes and any other illness judged by investigator to substantiate exclusion.
- •Subject has a history of significant other diseases.
- •Subject has a history of psychiatric disorders which would prevent compliance with study instructions
- •For female subjects, suspicion of pregnancy
- •Subject has received treatment with another investigational drug or device within the past 30 days
结局指标
主要结局
To determine the success rate in reaching within working distance of the Cecum with no complications.
时间窗: 1 month
次要结局
- To assess the ability to perform routine therapeutic interventions such as biopsies, polypectomies, APC etc. as compared to therapeutic interventions with standard colonoscopes found in the literature.(1 month)
研究者
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