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临床试验/NCT02477124
NCT02477124终止不适用

A See and Treat Paradigm for Cervical Pre-cancer

Duke University6 个研究点 分布在 5 个国家目标入组 514 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
514
试验地点
6
主要终点
Number of Participants for Which the Standard of Care Diagnosis and the Diagnosis of the TVDC Image Agree

研究概览

简要总结

The purpose of this study is to see if the transvaginal colposcope produces similar results to colposcopy for the screening of cervical cancer. In this study the investigators are using an investigational device called the transvaginal colposcope. The word investigational means that the device is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients undergoing cervicography OR colposcopy OR VIA OR patients undergoing LEEP for the treatment of cervical cancer.
  • Age 25 and greater
  • Patients of all ethnic backgrounds will be included.
  • Ability to understand and the willingness to sign a written informed consent document.

排除标准

  • Children and subjects under 25.

结局指标

主要结局

Number of Participants for Which the Standard of Care Diagnosis and the Diagnosis of the TVDC Image Agree

时间窗: Up to approximately 10 minutes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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A See and Treat Paradigm for Cervical Pre-cancer | 临床试验