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comparison of performance of portable colposcopes with standard colposcope in cervical cancer screening

A Crossover Randomized Study of Portable Transvaginal Colposcope and Hand-held Colposcope for Evaluation of Cervical Intraepithelial Neoplasia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012560
Enrollment
250
Registered
2018-03-15
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

Health Condition 1: null- cervical intraepithelial neoplasia

Interventions

Intervention1: Gynocular : Gynocular is a portable colposcope made in Sweden, used for diagnosing cervical precancerous lesions. Use single sitting -one day Intervention2: Pocket Trans vaginal Colpo

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria 1.Women with any of the following - Persistent vaginal discharge for more than 6 months - post coital bleeding - post-menopausal bleeding - unhealthy cervix on speculum examination 2.Referred for colposcopy with abnormal cervical cancer screening test results (Pap smear/HPV/VIA/VILI)

Exclusion criteria

Exclusion criteria: Exclusion criteria 1.Previous hysterectomy 2.Women with obvious growth on cervix 3.Pregnancy 4.Unwilling to participate

Design outcomes

Primary

MeasureTime frame
1.To compare the performance of two portable colposcopes (transvaginal colposcope and Gynocular®) with a standard colposcope in evaluation of cervix.Timepoint: 1.at the time of screening—

Secondary

MeasureTime frame
1.To compare the performance of VIA and HPV DNA testing with the portable colposcope and determine the optimal strategy in low resource setting 2.To compare the operatorâ??s experience in using portable colposcopes with respect to ease of use and optical characteristics including resolution, field of view, magnification, and depth of field. Timepoint: single visit—

Countries

India

Contacts

Public ContactJayashree Natarajan

All India Institute of Medical sciences, New Delhi

neerja.bhatla07@gmail.com9731024312

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026