跳至主要内容
临床试验/CTRI/2017/08/009335
CTRI/2017/08/009335招募中Unknown

A Pilot Study to evaluate a smart-phone based cervical imaging device in Cervical Cancer Screening Program - A Indian Study

Mobile Optical Detection Technologies6 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2017年3月15日最近更新:

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
600
试验地点
6
主要终点
Increase of negative predictive value (NPV) of the primary screening test to reduce unnecessary referrals to colposcopy and increase of positive predictive value (PPV) in the primary screening test around staging of pre-cancer and cancer, to ensure that women who are at risk for cervical cancer are caught in time for treatment

研究概览

简要总结

Thestudy will aim to evaluate the enhanced visualization of the cervical cancer screeningprocedure in correlation with the current Visualization with Acetic Acid (VIA)and/or Visualization with Lugol’s Iodine (VILI), followed by Pap Smear.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • Subject is able to read, understand and sign the informed consent form.

排除标准

  • Subjects with documented dementia or any other mental disorders, which would render them unable to cooperate with the study requirements Not willing to sign Informed Consent Form.

结局指标

主要结局

Increase of negative predictive value (NPV) of the primary screening test to reduce unnecessary referrals to colposcopy and increase of positive predictive value (PPV) in the primary screening test around staging of pre-cancer and cancer, to ensure that women who are at risk for cervical cancer are caught in time for treatment

时间窗: day 1

次要结局

未报告次要终点

研究者

发起方
Mobile Optical Detection Technologies
申办方类型
Pharmaceutical industry-Global

研究点 (6)

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