NCT00751998已完成不适用
A Clinical Registry to Assess Performance and Clinical Utility of the SpyGlass Direct Visualization System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 297
- 试验地点
- 15
- 主要终点
- Procedural Success as Defined by: 1. Ability to Visualize Stricture & Obtain Biopsy of Lesion Adequate for Histological Examination in Suspected Malignancy Cases or 2. Ability to Visualize Stone(s) & Successfully Initiate Stone Fragmentation & Removal.
研究概览
简要总结
A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Male or female >= 18 years of age
- •Willing and able to comply with the Registry procedures and provide written informed consent to participate in the Registry
- •Indicated for ERCP or ERCP/cholangioscopy (with or without biopsy)
排除标准
- •Subjects for whom endoscopic procedure are medically contraindicated
- •Subjects for whom ERCP are medically contraindicated
- •Subjects for whom medical condition warrants use of device outside of indication for use
结局指标
主要结局
Procedural Success as Defined by: 1. Ability to Visualize Stricture & Obtain Biopsy of Lesion Adequate for Histological Examination in Suspected Malignancy Cases or 2. Ability to Visualize Stone(s) & Successfully Initiate Stone Fragmentation & Removal.
时间窗: During Procedure
次要结局
未报告次要终点
研究者
研究点 (15)
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