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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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