CTRI Number |
CTRI/2018/03/012560 [Registered on: 15/03/2018] Trial Registered Retrospectively |
Last Modified On: |
12/03/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Screening |
Study Design |
Randomized, Crossover Trial |
Public Title of Study
|
comparison of performance of portable colposcopes with standard colposcope in cervical cancer screening |
Scientific Title of Study
|
A Crossover Randomized Study of Portable Transvaginal Colposcope and Hand-held Colposcope for Evaluation of Cervical Intraepithelial Neoplasia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
Nil |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Jayashree Natarajan |
Designation |
Senior Resident |
Affiliation |
All India Institute of Medical sciences, New Delhi |
Address |
Department of Obstetrics and Gynaecology,
All India Indsitute of Medical Sciences,
Ansari Nagar,
New Delhi
New Delhi DELHI 110029 India |
Phone |
9731024312 |
Fax |
|
Email |
vassnthjayashree@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DrNeerja Bhatla |
Designation |
Professor |
Affiliation |
All India Institute of Medical sciences, New Delhi |
Address |
Department of Obstetrics and Gynaecology,
All India Indsitute of Medical Sciences,
Ansari Nagar,
New Delhi
New Delhi DELHI 110029 India |
Phone |
9731024312 |
Fax |
|
Email |
neerja.bhatla07@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Jayashree Natarajan |
Designation |
Senior Resident |
Affiliation |
All India Institute of Medical sciences, New Delhi |
Address |
Department of Obstetrics and Gynaecology,
All India Indsitute of Medical Sciences,
Ansari Nagar,
New Delhi
New Delhi DELHI 110029 India |
Phone |
9731024312 |
Fax |
|
Email |
vassnthjayashree@gmail.com |
|
Source of Monetary or Material Support
|
Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi,
PIN-110029 |
|
Primary Sponsor
|
Name |
All India Institute of Medical Sciences New Delhi |
Address |
All India Institute of Medical Sciences, New Delhi,
PIN-110029 |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Jayashree Natarajan |
All India Institute of Medical Sciences, New Delhi |
Department of Obstetrics and Gynaecology,
All India Institute of Medical Sciences, New Delhi New Delhi DELHI |
9731024312
vassnthjayashree@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics Committee for Postgraduate Research, AIIMS, New Delhi |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
cervical intraepithelial neoplasia, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Gynocular
|
Gynocular is a portable colposcope made in Sweden, used for diagnosing cervical precancerous lesions.
Use single sitting -one day |
Intervention |
Pocket Trans vaginal Colposcope |
Pocket Trans vaginal Colposcope is made by Duke university,NC, USA, used for screening cervical precancerous lesion.
Use -Single sitting -one day |
Comparator Agent |
Standard videocolposcope |
The presently used device for colposcopy.
Use -Single sitting, one day |
|
Inclusion Criteria
|
Age From |
21.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Female |
Details |
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)
|
|
ExclusionCriteria |
Details |
Exclusion criteria
1.Previous hysterectomy
2.Women with obvious growth on cervix
3.Pregnancy
4.Unwilling to participate
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1.To compare the performance of two portable colposcopes (transvaginal colposcope and Gynocular®) with a standard colposcope in evaluation of cervix. |
1.at the time of screening |
|
Secondary Outcome
|
Outcome |
TimePoints |
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 operator’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.
|
single visit |
|
Target Sample Size
|
Total Sample Size="250" Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
28/08/2017 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="10" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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 Gynocular® (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 Gynocular® colposcope in detecting cervical intraepithelial. |