跳至主要内容
临床试验/CTRI/2022/09/045943
CTRI/2022/09/045943尚未招募不适用

Evaluation of Artificial Intelligence based assessment of Smart Scope® images for single visit cervix cancer screening in low resource setting: A retrospective study

Periwinkle Technologies Pvt Ltd3 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2022年1月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,500
试验地点
3
主要终点
Non-inferiority evaluation of Artificial Intelligence based assessment with expert’s

研究概览

简要总结

Cancer of the cervix is a leading cause of death in Indian women and contributes to nearly one fourth of the world burden of cervical cancer incidence and mortality. Access to screening and health services is a major barrier for success in cervical cancer screening programs. Present screening tests such as Pap test, visual inspection with acetic acid (VIA) test, HPV test have their own limitations.

Periwinkle Technologies has developed a portable, easy-to-use, electricity independent, trans-vaginal digital device, “Smart Scope ® CX†(SSCX) for cervical health checkup. It offers digital logs and allows diagnostic triaging through remote consultation. It captures digital cervical images and allows remote expert referral too if required.

To remove the subjectivity of VIA test and to reduce the burden of diagnostic triaging on tertiary care experts albeit remotely, Artificial Intelligence (AI) based auto- image - assessment feature has been introduced in the software platform of Smart Scope®. This is expected to provide single visit immediate auto-assessment of cervical health.

Over a past few years Smart Scope is being used for cervical health checkups, with the consent of participant, in various affiliated Anganwadies, PHCs, UHTC, RHTC, OPD and in health checkup camps for clear, close and magnified visualization of cervix. Lakhs of images have been captured using Smart Scope.   The above mentioned centers will be contacted and the uterine cervix images of the women who were screened using smart scope will be obtained from these centers.  The images will be  loaded on 3 Tabs and will be given to  3 expert colposcopist for evaluation of cervix health.  These experts will be blinded to  each others opinion.  Simultaneously the same images will be auto-analyzed using AI software developed by Periwinkle Technologies. Accuracy of AI will be calculated based on comparison of AI outcome and Expert’s assessment.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Woman underwent cervical screening using the Smart Scope device.
  • Aged 25–65 years
  • Non-Pregnant
  • No history of prior treatment for cancer of the cervix
  • No history of hysterectomy
  • Healthy enough to undergo pelvic examination.

排除标准

  • Women not screened using Smart Scope.

结局指标

主要结局

Non-inferiority evaluation of Artificial Intelligence based assessment with expert’s

时间窗: around 12 months after CTRI registration

assessment of Smart Scope® cervix images (AI Vs expert)

时间窗: around 12 months after CTRI registration

次要结局

  • Non-inferiority evaluation of AI based assessment of cervix using Smart Scope®(with histopathology assessment wherever available (AI Vs Histopath))

研究者

发起方
Periwinkle Technologies Pvt Ltd
申办方类型
Other [privet company]

研究点 (3)

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