Development and evaluation of a portable digital colposcope with smartphone view during cervix cancer screening visit in low resource setting

Phase II-Development and non-inferiority evaluation of a portable transvaginal digital colposcope with smartphone interface for single visit cervix cancer screening in low resource setting

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

CTRI

Registry ID

CTRI/2018/07/014980

Enrollment

600

Registered

2018-07-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Portable Trans vaginal digital colposcope: To indigenously develop technology for a cost effective device to be used in low resource setting that incorporates all functions of a colposc

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

India

Contacts

Public ContactDr Sharmila Pimple

Tata Memorial Hospital

pimplesa@tmc.gov.in9223207939

Outcome results