None listed
Conditions
Interventions
Intervention1: Human Expert Group: This intervention involves the assessment by a group of 5-7 gynaecologists (the Human Expert Group) of digital images of cervix treated with 5% acetic acid as per VI
uding interventions 9 Months
Intervention2: PredAID-CerVIA: PredAID-CERVIA is a smartphone app developed to automate decision-making following the VIA procedure and make it expert agnostic. The syste
uding interventions 9 Months
Control Intervention1: Conventional cervical cytology (Pap smear): This arm involves the conventional cervical cytology (Pap smear tests) of all study participants to gene
uding interventions 9 Months
Sponsors
BlockAppsAI Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1)Women aged between 25 and 65 years of age, inclusive. 2)Participants should have a history of sexual activity.
Exclusion criteria
Exclusion criteria: 1)Menstruating women 2)Pregnant women women who have had childbirth with 6 weeks prior to the date of test 3)Women who have had hysterectomy 4)Women who have vaginal infections, discharge etc. at the time of the test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Specificity, sensitivity, PPV and NPV of prediction of VIA classes, namely, "Positive", "Negative" or "Suspicious for Cancer" by PredAID-CerVIA and a group of experienced gynecologists (Human Expert Group), taking a combination of conventional cytology (Pap smear) and physicians verdict as reference.Timepoint: 9 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome: Measure of the subjects experience, and opinion of the VIA procedure based on the following criteria ââ?¬â?? level of comfort, level of comfort with smartphone camera-based image acquisition the likelihood of repeating the test on a yearly two-yearly or five-yearly basisTimepoint: 9 Months | — |
Countries
India
Contacts
Public ContactSridhar Yilapavanam
BlockAppsAI Pvt Ltd
Outcome results
None listed