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CTRI Number  CTRI/2017/08/009335 [Registered on: 10/08/2017] Trial Registered Retrospectively
Last Modified On: 14/07/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Single Arm Study 
Public Title of Study   Cancer testing 
Scientific Title of Study   A Pilot Study to evaluate a smart-phone based cervical imaging device in Cervical Cancer Screening Program - A Indian Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
APMDOT/01-12/16  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mallika Samuel 
Designation  Lead Investigator 
Affiliation   
Address  Sr Consultant Gynecology Gynecology and Obstetrics Dept Apollo FirstMed Hospitals Chennai

Chennai
TAMIL NADU
600006
India 
Phone    
Fax    
Email  mallikamsamuel@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mallika Samuel 
Designation  Lead Investigator 
Affiliation   
Address  Sr Consultant Gynecology Gynecology and Obstetrics Dept Apollo FirstMed Hospitals Chennai

Chennai
TAMIL NADU
600006
India 
Phone    
Fax    
Email  mallikamsamuel@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mallika Samuel 
Designation  Lead Investigator 
Affiliation   
Address  Sr Consultant Gynecology Gynecology and Obstetrics Dept Apollo FirstMed Hospitals Chennai

Chennai
TAMIL NADU
600006
India 
Phone    
Fax    
Email  mallikamsamuel@gmail.com  
 
Source of Monetary or Material Support  
International Finanace Corporations Tech Merge Program Nelson Mandela Road Vasant Kunj New Delhi 
Mobile ODT Ben Avigdor 8, Tel Aviv Isreal 
 
Primary Sponsor  
Name  Mobile Optical Detection Technologies 
Address  Ben Avigdor 8, Tel Aviv, Israel 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
International Finance Corporation   Nelson Mandela Road Vasant Kunj New Delhi 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mallika Samuel  Apollo FirstMed Hospitals  Dept of gynecology and obstetrics, 154 Poonamallee High Road Chennai.
Chennai
TAMIL NADU 		 044

mallikamsamuel@gmail.com 
Dr Krishna Kumari  Apollo Health City  Dept of gynecology and obstetrics, Apollo Institute of Medical Sciences & Research
Hyderabad
ANDHRA PRADESH 		 60601066

doc_krishnak@yahoo.co.in 
Dr Chitra Ramamurty  Apollo Hospitals  Dept of gynecology and obstetrics, Bannerghatta Road, Bangalore.
Bangalore
KARNATAKA 		 080

bingiramamurthy@yahoo.co.in 
Dr Aruna  Apollo Speciality Hospital  Dept of gynecology and obstetrics, Aynambakkan, Chennai
Chennai
TAMIL NADU 		 26537777

draruna75@gmail.com 
Dr Hemalekha  Apollo Speciality Hospital  Dept of gynecology and obstetrics K K Nagar Madurai
Madurai
TAMIL NADU 		 2580892

drkhleka@yahoo.co.in 
Dr Sangamithirae  Apollo Tondiarpet Hospital  Dept of gynecology and obstetrics, 645 T H Road Tondiarpet Chennai
Chennai
TAMIL NADU 		 044

dsangamithirae@yahoo.com 
Dr SRajagopal  Apollo Total Health  Dept of gynecology and obstetrics Aragonda Village
Chittoor
ANDHRA PRADESH 		 08573284283

drrajgopal_s@apollohospitals.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Institutional Ethics Committee - Clinical Studies  Approved 
Institutional Ethics Committee - Clinical Studies  Approved 
Institutional Ethics Committee - Clinical Studies  Approved 
Institutional Ethics Committee - Clinical Studies  Approved 
Institutional Ethics Committee - Clinical Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Cervical Screening,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Subject is able to read, understand and sign the informed consent form 
 
ExclusionCriteria 
Details  Subjects with documented dementia or any other mental disorders, which would render them unable to cooperate with the study requirements
Not willing to sign Informed Consent Form 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Increase of negative predictive value (NPV) of the primary screening test to reduce unnecessary referrals to colposcopy and increase of positive predictive value (PPV) in the primary screening test around staging of pre-cancer and cancer, to ensure that women who are at risk for cervical cancer are caught in time for treatment  day 1 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   15/03/2017 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The study will aim to evaluate the enhanced visualization of the cervical cancer screening procedure in correlation with the current Visualization with Acetic Acid (VIA) and/or Visualization with Lugol’s Iodine (VILI), followed by Pap Smear. 
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