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Comparison of Smart Scope® auto assessment and Colposcopy assessment for cervical health screening.

Validation of automated assessment (AI) of cervical images captured by Smart Scope® (SS) against colposcopy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/04/041568
Enrollment
150
Registered
2022-04-01
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

None listed

Interventions

None listed

Sponsors

Periwinkle Technologies Pvt Ltd
Lead Sponsor
Bharati Hospital ANd Research Center
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Sexually active women aged 25â??65 years Non Pregnant No history of prior treatment for cancer of the cervix No history of hysterectomy Healthy enough to undergo pelvic examination i.e. not seriously ill with a debilitating condition

Exclusion criteria

Exclusion criteria: Women with a known diagnosis of cancer, any other terminal diagnosis

Design outcomes

Primary

MeasureTime frame
validation of SS-AI for categorizing the cervical health against colposcopyTimepoint: at around 11 months in enrolment process

Secondary

MeasureTime frame
1. Validate SS-AI and COL assessment with histopathology 2. Non-inferiority evaluation of SS-AI assessments by comparing with COL assessment 3. Estimate sensitivity and specificity of SS-AI and COLTimepoint: 1. At the time of histology result 2. At the time of screening with Smart Scope and colposcope 3. At the time of histopathology result

Countries

India

Contacts

Public ContactDr Manju Talathi

Bharati Vidyapeeth Medical College Pune

manjutalathi@yahoo.in9822884366

Outcome results

None listed

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