None listed
Conditions
Interventions
Control Intervention1: Agreeement of bimodal transvaginal multispectral imaging probe high
grade lesion with the colposcopic high
grade lesion (Swede Score more than 5)
: Agreeement of bimodal transva
Sponsors
DST-SERB ANRF
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: Above 21 years and up to 75 years 2. Female OPD patients 3. Screen positive patients coming for colposcopy Having any one of the following: a. Pap smear- ASCUS, ASCUS H, LSIL, HSIL b. VIA/VILI Abnormal report c. HPV DNA positive
Exclusion criteria
Exclusion criteria: 1. Post hysterectomy 2. Menstruating at the time of visit 3. Pregnant at the time of visit 4. Active cervicitis or vulvovaginitis 5. Obvious growth in cervix suggestive of cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To see the agreement of bimodal transvaginal imaging probe to detect high grade lesions with colposcopic high grade lesion (Swede colposcopy index more than 5). 2.To determine the diagnostic accuracy of bimodal transvaginal multispectral imaging probe in comparison to standard coposcopy to detect premalignant lesions (CIN2 or CIN3 - pathology).Timepoint: The bimodal transvaginal multispectral imaging probe will freeze by May, 2025 and the recruitment will start from 1st June, 2025. | — |
Secondary
| Measure | Time frame |
|---|---|
| Find the sensitivity and specificity of the bimodal transvaginal multi spectral probe probe to detect preinvasive cervical lesion.Timepoint: Within 6 months of the completion of the first phase of the trial | — |
Countries
India
Contacts
Public ContactDr Arpitha A
JIPMER
Outcome results
None listed