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Evaluation of machine learning model for auto assessment of cervical health using Smart Scope

An observational study to determine the performance of Machine Learning model for auto assessment of cervical screening images obtained using Smart Scope - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/09/021261
Enrollment
300
Registered
2019-09-16
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 Machine Learning-enabled automatic assessment of VIA-VILI images: Blinded auto-assessment of digital cervical VIA-VILI images captured with trans vag

Sponsors

Periwinkle Technologies Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Sexually active women 2. Age between 25 and 65 years 3. Those who have volunteered for Smart Scope test in routine OPD or in specially arranged health camps

Exclusion criteria

Exclusion criteria: 1. Pregnant women 2. Women with prior colposcopy or any other cervical / vaginal / uterine procedure done within the last one month 3. Women with vaginal bleeding or earlier known frank cancer 4. Women who have had hysterectomy

Design outcomes

Primary

MeasureTime frame
Auto assessment and manual assessment of digital images obtained using Smart Scope into three categories viz., normal (green) / abnormal benign changes (amber) / pre-cancerous & cancerous changes (red).Timepoint: Immediately after screening by VIA with 5% Acetic acid and VILI by Lugols Iodine

Secondary

MeasureTime frame
Categorization by auto assessment of digital images of VIA-VILITimepoint: During Smart Scope aided VIA-VILI Test;Categorization into three categories ie. Green/ Amber/ Red among women screened by manual assessment of digital VIA-VILI imagesTimepoint: During Smart Scope aided VIA-VILI Test;Confirmation of CIN and CA cases by conventional colposcopyTimepoint: During standard colposcopy;Histopathology confirmed Cervical Intraepithelial neoplasiaTimepoint: After histo-pathology report of sample taken during colpo-guided biopsy

Countries

India

Contacts

Public ContactMs Veena Moktali

Periwinkle Technologies Pvt. Ltd.,

vrmoktali@periwinkletech.com919881235459

Outcome results

None listed

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