None listed
Conditions
Interventions
Control Intervention1: Agreeement of opto electric probe high grade lesion with the colposcopic high grade lesion (Swede Score 5): Agreeement of opto electric probe high grade lesion with the colposc
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: Above 18 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 opto-electric bimodal transvagi-nal imaging probe to detect high grade lesions with colpo-scopic high grade lesion (Swede colposcopy index more than 5). 2.To determine the diagnostic accuracy of bimodal trans-vaginal multispectral imaging probe in comparison to standard coposcopy to detect premalignant lesions (CIN2 or CIN3 - pathology).Timepoint: The opto-electric probe will freeze by 12 weeks and the recruitment will start from 1st July, 2025. | — |
Secondary
| Measure | Time frame |
|---|---|
| Find the sensitivity and specificity of the opto-electric 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
Jawaharlal Institute of Postgraduate Medical Education and Research
Outcome results
None listed