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Assessment of Accuracy of Smart Scope Screening device for Cervical Cancer

Assessment of Predictive Accuracy of Indian-Make Artificial intelligence enabled Smart Scope as Point-of-Care Screening and Triaging tool for Cervical Cancer Screening - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/08/092500
Enrollment
160
Registered
2025-08-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N72- Inflammatory disease of cervix uteri

Interventions

Intervention1: Nil: Nil

Sponsors

Government Institute of Medical Sciences(GIMS)
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1.Pregnant women. 2.Women with a history of prior treatment for cervical cancer. 3.Women with a history of hysterectomy.

Design outcomes

Primary

MeasureTime frame
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. 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. Timepoint: From baseline to end of study at day7 week 1

Secondary

MeasureTime frame
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. Timepoint: From baseline to end of study at day 7 week 1

Countries

India

Contacts

Public ContactDr Garima Singh

Government Institute of Medical Sciences(GIMS)

garima002singh@gmail.com9794371207

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026