NCT00358111终止4 期
A Single Arm Multi-Center Post Approval Study of LUMA as Adjunct to Colposcopy
SpectraScience4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2006年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Relationship between HPV and the performance of the LUMA system as an adjunct to colposcopy for detection of CIN 2,3+ will be assessed.
研究概览
简要总结
This is a post-approval, multi-center, single-arm study (n=950) designed to address the relationship of the LUMA device performance to patient age, patient human papillomavirus (HPV) status and colposcopist experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Documented abnormal pap test
排除标准
- 未提供
结局指标
主要结局
Relationship between HPV and the performance of the LUMA system as an adjunct to colposcopy for detection of CIN 2,3+ will be assessed.
时间窗: ongoing - estimated at 3 years
次要结局
未报告次要终点
研究者
研究点 (4)
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