Development and evaluation of a portable digital colposcope with smartphone view during cervix cancer screening visit in low resource setting
Phase 2
- Registration Number
- CTRI/2018/07/014980
- Lead Sponsor
- Biotechnology Industry Research Assistance council BIRACDBT under IIPME
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Sexually active women aged 30â??65 years.
2. Non Pregnant.
3. No history of prior treatment for cancer of the cervix.
3. No history of hysterectomy.
4. Healthy enough to undergo pelvic examination i.e. not seriously ill with a debilitating condition.
Exclusion Criteria
1. Women with a known diagnosis of cancer, any other terminal diagnosis.
2. Not willing for cervical cancer screening.
3. Not willing for follow up.
4. Potential subjects failing any one of these criteria will be excluded from the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Test positivity rates by Conventional Colposcopy and TVDC for further assessment of cervical cancer riskTimepoint: After screened positive for primary screening by Visual Inspection with 5% Acetic Acid
- Secondary Outcome Measures
Name Time Method Histopathological confirmed Cervical Intraepithelial neoplasiaTimepoint: 8 days after HPR sampling;Prevalence of Cervical Intraepithelial Neoplasia (CIN) among women screened by primary screening test VIATimepoint: VIA positives during the primary screening test;Prevalence of CIN by Conventional ColposcopyTimepoint: During Conventional colposcopy;Prevalence of CIN by Transvaginal Digital Colposcopy (TVDC)Timepoint: During Transvaginal Digital Colposcopy (TVDC)