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

Recruiting

Conditions: cervical intraepithelial neoplasia

Registration Number: CTRI/2018/03/012560

Lead Sponsor: All India Institute of Medical Sciences New Delhi

Brief Summary: Cervical cancer is a major health concern in Indian women. Though it can be prevented and detected at early stage, screening for cervical cancer has not reached the target population as desired. The logistical issues in screening is a major draw back in screening programmes. The standard binocular colposcopes available at present are costly and due to their size need a place of examination separately. Carrying a colposcope to cervical cancer screening camps creates logistic problems not only due to size and need for separate examination room but also power supply.

The GynocularÂ® (Gynius AB, Stockholm, Sweden) is a pocket-size hand held monocular colposcope with 5x to 12x magnification, LED illumination, green filter, rechargeable battery and can be mounted on a camera tripod. Optics, resolution and illumination are comparable with a standard colposcope. It is approved as an investigational product by the Swedish National Drug Authority as a noninvasive medical diagnostic class I tool.

The POCkeT transvaginal colposcope is a colposcope which has been developed at Duke University. It consists of a consumer grade digital camera found in the commonly used iPhone (Apple iPhone 4) and consumer grade light emitting diodes (LEDs) used in standard colposcopes, (LeisegangOptik 2), which all fit into the form factor of a tampon, a common feminine hygiene product. It comes with its own light source.

The goal of the present study is to conduct a side-by-side comparison of the performance of transvaginal colposcope to GynocularÂ® colposcope in detecting cervical intraepithelial.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 250

Inclusion Criteria

Inclusion criteria 1.Women with any of the following.
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 1.Previous hysterectomy 2.Women with obvious growth on cervix 3.Pregnancy 4.Unwilling to participate.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To compare the performance of two portable colposcopes (transvaginal colposcope and GynocularÂ®) with a standard colposcope in evaluation of cervix.	1.at the time of screening

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1): All India Institute of Medical Sciences, New Delhi
🇮🇳
Delhi, DELHI, India
All India Institute of Medical Sciences, New Delhi
🇮🇳Delhi, DELHI, India
Dr Jayashree Natarajan
Principal investigator
9731024312
vassnthjayashree@gmail.com