NCT02272075已完成不适用
Image Comparison of a Mobile Colposcope (SmartScope) vs. a Standard Colposcope for Directing Cervical Biopsies in Women With Abnormal Pap Smears: A Non-inferiority Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- image non-inferiority
研究概览
简要总结
This trial will compare images obtained from a mobile colposcope with those obtained using a standard of care.
详细描述
This trial will compare images obtained from a mobile colposcope with those obtained using a standard colposcope in women with abnormal pap smears. It is a non-inferiority trial. Blinded images will be evaluated be experts in colpsocopy and compared
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •abnormal cervical cancer screening by pap smear of high risk HPV test -
排除标准
- 未提供
研究组 & 干预措施
Standard of Care
No Intervention
Standard of Care
active colposcope
Active Comparator
Mobile OCT M3 scope
干预措施: Mobile OCT M3 scope (Device)
结局指标
主要结局
image non-inferiority
时间窗: 6 months
imafge non-inferiority
次要结局
未报告次要终点
研究者
研究点 (1)
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