To see how accurate is Artifical Intelligence technology incorporated into a transvaginal digital screening device for detecting pre-cancerous conditions in the cervix

Validation of Digital Automated Image Assessment of Images Captured by Trans Vaginal Device as Primary Method for Cervical Cancer Screening

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/07/035164

Enrollment

500

Registered

2021-07-27

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

Health Condition 1: 1- Obstetrics

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: a) Sexually active women aged 25 to 65 years b) Non Pregnant c) Healthy enough to undergo pelvic examination i.e. not seriously ill with any debilitating condition

Exclusion criteria

Exclusion criteria: Previous treatment for precancerous lesions/cancer of the cervix b) Woman who had hysterectomy c) Women with a known diagnosis of cancer, any other terminal diagnosis d) Not willing to undergo cervical cancer screening e) Not willing for follow up f) Potential subjects failing any one of these g) As decided by Investigator

Design outcomes

Primary

Measure	Time frame
Sensitivity, specificity positive predictive value and negative predictive value of SS-AI compared with the reference standard of expert assessment of colposcopy image and /or histopathology.Timepoint: 6 months	—

Secondary

Measure	Time frame
Accuracy of SS AI in predicting the final histology and predictive valu of SS AI to predict high grade CINTimepoint: 6 months	—

Countries

India

Contacts

Public ContactDr Saritha Shamsunder

vardhman mahavir medical college and safdarjung hospital

sss.safdarjung2002@gmail.com01126730681

Outcome results