Assessment of Predictive Accuracy of Indian-Make Artificial intelligence enabled Smart Scope as Point-of-Care Screening and Triaging tool for Cervical Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- 1.To assess the sensitivity, specificity, NPV, and PPV of Artificial intelligence enabled Smart Scope (AI-SS), Visual Inspection after Acetic acid application VIA/ Visual Inspection after Lugol’s Iodine application VILI, and colposcopy in comparison with histopathology.
研究概览
简要总结
MATERIALS AND METHODS
Study Design**:** Prospective observational study
Study Setting: Department of Obstetrics and Gynaecology, Government Institute of Medical
Sciences (GIMS), Greater Noida, Uttar Pradesh
Study Duration: 12 months
Study Population: Women attending the gynaecology outpatient department (OPD) at GIMS.
Inclusion Criteria:
1. Sexually active women aged between 25 and 65 years.
2. Women presenting with complaints of white discharge per vagina, vaginal itching, or lower abdominal pain.
3. Women with abnormal per vaginal bleeding.
4. Women found to have a clinically unhealthy cervix on per speculum examination.
Exclusion Criteria:
1. Pregnant women.
2. Women with a history of prior treatment for cervical cancer.
3. Women with a history of hysterectomy.
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
- •1.Sexually active women aged between 25 and 65 years.
- •2.Women presenting with complaints of white discharge per vagina, vaginal itching, or lower abdominal pain.
- •3.Women with abnormal per vaginal bleeding.
- •4.Women found to have a clinically unhealthy cervix on per speculum examination.
排除标准
- •1.Pregnant women.
- •2.Women with a history of prior treatment for cervical cancer.
- •3.Women with a history of hysterectomy.
结局指标
主要结局
1.To assess the sensitivity, specificity, NPV, and PPV of Artificial intelligence enabled Smart Scope (AI-SS), Visual Inspection after Acetic acid application VIA/ Visual Inspection after Lugol’s Iodine application VILI, and colposcopy in comparison with histopathology.
时间窗: From baseline to end of study at day7 week 1
2.To compare the sensitivity, specificity, NPV, and PPV of Artificial intelligence enabled Smart Scope (AI-SS) with that of the Visual Inspection after Acetic acid application VIA/ Visual Inspection after Lugol’s Iodine application VILI and colposcopy.
时间窗: From baseline to end of study at day7 week 1
次要结局
- 1.To assess the sensitivity, specificity, NPV, and PPV of PAPs in comparison with histopathology.(2.To assess satisfaction of healthcare workers to the Smart Scope procedure.)
研究者
Dr Ritu Sharma
Government Institute of Medical Sciences (GIMS)