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临床试验/CTRI/2025/09/094065
CTRI/2025/09/094065尚未招募不适用

Development of a Transvaginal Probe-based Dermatoscope with Automated AI-enabled decision support for detection of cancers and Infections.

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
10,000
试验地点
1
主要终点
Development of a transvaginal probe-based dermatoscope

研究概览

简要总结

Women’s health is increasingly recognized as a critical public health issue. Gynecological exams are essential for sexual and reproductive health research, including screening for cervical cancer and infections. These exams typically involve external inspection, speculum examination, and bimanual palpation. However, they often cause discomfort due to pain, anxiety, and emotional distress, especially in prepubertal and post-menopausal women. Diagnosis of STIs/RTIs in many healthcare settings relies heavily on speculum-assisted visual inspection due to limited resources and a shortage of trained professionals. This often leads to inadequate care and over-reliance on syndromic management. To address these challenges, we propose developing a digital transvaginal dermatoscope with AI-enabled decision support for automated detection of vaginal and cervical pathologies. This innovation aims to provide a safe, non-traumatic, and accurate alternative to traditional gynecological exams, improving women’s healthcare significantly.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Reproductive age group (18-45 years) sexually active women attending the STD Clinic of Dermatology and Venereology and Obstetrics and Gynecology OPD will be enrolled in the study with prior informed consent.

排除标准

  • Pre-menopausal, post-menopausal, pregnant or lactating women.

结局指标

主要结局

Development of a transvaginal probe-based dermatoscope

时间窗: At baseline

次要结局

  • 1. Development of an AI-enabled decision support system for diagnosis of vaginal and cervical pathologies using clinical images and patient metadata 2. Validation of the transvaginal probe-based dermatoscope with automated AI-enabled decision support against routine clinical management of STIs/RTIs in women(36 Months)

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Somesh Gupta

All India Institute of Medical Sciences

研究点 (1)

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