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Comparative performance evaluation of Artificial Intelligence (AI) based visual inspection test (AI_VIA) with Primary Health Worker administered VIA (PHW_VIA), HPV DNA test and cervical cytology to detect cervical pre-cancer lesions.

Comparative performance evaluation of Artificial Intelligence (AI) based visual inspection test (AI_VIA) with Primary Health Worker administered VIA (PHW_VIA), HPV DNA test and cervical cytology to detect cervical pre-cancer lesions. - AI_VIA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/12/022368
Enrollment
600
Registered
2019-12-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Artificial Intelligence (AI) based visual inspection test (AI_VIA): Digital images of ectocervix will be obtained using AI-enabled digital camera-based system by trained health worker f

Sponsors

Periwinkle Technologies Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Sexually active women aged 30â??60 years 2. Non Pregnant 3. No history of prior treatment for cancer of the cervix 4. No history of hysterectomy 5. Healthy enough to undergo pelvic examination i.e. not seriously ill with any debilitating condition

Exclusion criteria

Exclusion criteria: 1. Women with a known diagnosis of cancer, any other terminal diagnosis 2. Not willing to undergo cervical cancer screening

Design outcomes

Primary

MeasureTime frame
The study will demonstrate the proof-of-principle of an â??automated visual evaluationâ?? algorithm applied to archived, digitized cervical images for detection of cervical pre cancer lesionsTimepoint: 12 months—

Secondary

MeasureTime frame
1. Assessment of PHW_VIA 2. Assessment of HPV_DNA test 3. Assessment of cervical cytology 4. Colposcopic assessment to detect test positive cases (CIN lesions ) 5. Histopathology outcome Timepoint: 1. Immediately after PHW-VIA test 2. Fifteen (15) days after sampling for HPV DNA test 3. Four (4) days after sampling for cervical cytology 4. On same day followed by PHW-VIA test , immediately after colposcopy test 5. Eight to ten ( 8 to 10) days after biopsy—

Countries

India

Contacts

Public ContactDr Sharmila Pimple

Tata Memorial Hospital

drsharmilapatil@yahoo.com9223207939

Outcome results

None listed

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