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CTRI Number  CTRI/2022/09/045943 [Registered on: 27/09/2022] Trial Registered Prospectively
Last Modified On: 19/09/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective analysis of data 
Study Design  Other 
Public Title of Study   Artificial Intelligence based assessment for cervix cancer: A retrospective study 
Scientific Title of Study   Evaluation of Artificial Intelligence based assessment of Smart Scope® images for single visit cervix cancer screening in low resource setting: A retrospective study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manju Talathi 
Designation  Asst Prof 
Affiliation  Bharati Vidyapeeth Medical College Pune 
Address  Dept of Obs and Gynecology, BVDU Pune MAHARASHTRA 411043 India

Pune
MAHARASHTRA
411043
India 
Phone  91-9822884366   
Fax    
Email  manjutalathi@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Manju Talathi 
Designation  Asst Prof 
Affiliation  Bharati Vidyapeeth Medical College Pune 
Address  Dept of Obs and Gynecology, BVDU Pune MAHARASHTRA 411043 India


MAHARASHTRA
411043
India 
Phone  91-9822884366   
Fax    
Email  manjutalathi@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Manju Talathi 
Designation  Asst Prof 
Affiliation  Bharati Vidyapeeth Medical College Pune 
Address  Dept of Obs and Gynecology, BVDU Pune MAHARASHTRA 411043 India


MAHARASHTRA
411043
India 
Phone  91-9822884366   
Fax    
Email  manjutalathi@yahoo.in  
 
Source of Monetary or Material Support  
Periwinkle Technologies Pvt Ltd, Pune  
 
Primary Sponsor  
Name  Periwinkle Technologies Pvt Ltd 
Address  100, NCL Innovation Park, Pashan, Pune, Maharashtra 
Type of Sponsor  Other [privet company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manju Talathi  Bharati Vidyapeeth Deemed University Hospital   OPD, Room no. 18, Gynecology Department
Pune
MAHARASHTRA 		 9822884366

manjutalathi@yahoo.in 
Dr Manju Talathi  Rural Health Training Centre.  Bharati Vidyapeeth Lavale. Tal. Mulashi.
Pune
MAHARASHTRA 		 9822884366

manjutalathi@yahoo.in 
Dr Manju Talathi  Urban Health Training Center  Bharati Vidyapeeth 468/5, RB Kumthekar Rd, Pantancha Gate (पंतांचा गोट), above Mahatma Gandhi Hospital, Sadashiv Peth
Pune
MAHARASHTRA 		 9822884366

manjutalathi@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth (Deemed to be University) Medical College Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Walk in women in the OPD or health camps in between 25 to 65 years of age and consenting for cervical screening  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Woman underwent cervical screening using the Smart Scope device.
2. Aged 25–65 years
3. Non-Pregnant
4. No history of prior treatment for cancer of the cervix
5. No history of hysterectomy
6. Healthy enough to undergo pelvic examination 
 
ExclusionCriteria 
Details  1. Women not screened using Smart Scope
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Non-inferiority evaluation of Artificial Intelligence based assessment with expert’s
assessment of Smart Scope® cervix images (AI Vs expert) 		 around 12 months after CTRI registration 
 
Secondary Outcome  
Outcome  TimePoints 
Non-inferiority evaluation of AI based assessment of cervix using Smart Scope®
with histopathology assessment wherever available (AI Vs Histopath) 		 At the end of 12th Month 
 
Target Sample Size   Total Sample Size="1500"
Sample Size from India="1500" 
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)   01/10/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Cancer of the cervix is a leading cause of death in Indian women and contributes to nearly one fourth of the world burden of cervical cancer incidence and mortality. Access to screening and health services is a major barrier for success in cervical cancer screening programs. Present screening tests such as Pap test, visual inspection with acetic acid (VIA) test, HPV test have their own limitations.

Periwinkle Technologies has developed a portable, easy-to-use, electricity independent, trans-vaginal digital device, “Smart Scope ® CX” (SSCX) for cervical health checkup. It offers digital logs and allows diagnostic triaging through remote consultation. It captures digital cervical images and allows remote expert referral too if required.

To remove the subjectivity of VIA test and to reduce the burden of diagnostic triaging on tertiary care experts albeit remotely, Artificial Intelligence (AI) based auto- image - assessment feature has been introduced in the software platform of Smart Scope®. This is expected to provide single visit immediate auto-assessment of cervical health. 

Over a past few years Smart Scope is being used for cervical health checkups, with the consent of participant, in various affiliated Anganwadies, PHCs, UHTC, RHTC, OPD and in health checkup camps for clear, close and magnified visualization of cervix. Lakhs of images have been captured using Smart Scope.   The above mentioned centers will be contacted and the uterine cervix images of the women who were screened using smart scope will be obtained from these centers.  The images will be  loaded on 3 Tabs and will be given to  3 expert colposcopist for evaluation of cervix health.  These experts will be blinded to  each others opinion.  Simultaneously the same images will be auto-analyzed using AI software developed by Periwinkle Technologies. Accuracy of AI will be calculated based on comparison of AI outcome and Expert’s assessment.
 
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