To see how accurate is the Artificial Intelligence incorporated into Mobile ODT device to detect pre-cancerous lesions of the cervix

Comparison of the accuracy of direct colposcopy reporting to a machine based algorithm using a mobile colposcopy device

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/08/036015

Enrollment

150

Registered

2021-08-27

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: R948- Abnormal results of function studies of other organs and systems

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: women aged 21-65years old women referred to colposcopy following an abnormal screening test (Pap or HPV or VIA+ve )

Exclusion criteria

Exclusion criteria: pregnancy, prior history of cervical cancer, prior history of cervical excisional procedure , hysterectomy.

Design outcomes

Primary

Measure	Time frame
performance of the machine learning algorithm against physicians colposcopic diagnaosis.Timepoint: At the point of assessment	—

Secondary

Measure	Time frame
evaluation of the AI technology against gold standard histopathology.Timepoint: imidiate	—

Countries

India

Contacts

Public ContactSaritha Shamsunder

Safdarjung Hospital

sss.safdarjung2002@gmail.com01126730681

Outcome results