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CTRI Number  CTRI/2025/09/094065 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   AI-Powered Vaginal Imaging Tool to Help Detect Cancer and Infections. 
Scientific Title of Study   Development of a Transvaginal Probe-based Dermatoscope with Automated AI-enabled decision support for detection of cancers and Infections. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Somesh Gupta 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  4064 4th floor Teaching block Department of Dermatology and Venereology All India Institute of Medical Sciences ANSARI NAGAR NEW DELHI 110029

New Delhi
DELHI
110029
India 
Phone  9868899120  
Fax    
Email  someshgupta@aiims.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Somesh Gupta 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  4064 4th floor Teaching block Department of Dermatology and Venereology All India Institute of Medical Sciences ANSARI NAGAR NEW DELHI 110029

New Delhi
DELHI
110029
India 
Phone  9868899120  
Fax    
Email  someshgupta@aiims.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Somesh Gupta 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  4064 4th floor Teaching block Department of Dermatology and Venereology All India Institute of Medical Sciences ANSARI NAGAR NEW DELHI 110029

New Delhi
DELHI
110029
India 
Phone  9868899120  
Fax    
Email  someshgupta@aiims.edu  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Indian Council of Medical Research Ansari Nagar Delhi 
Type of Sponsor  Government funding agency 
 
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 Somesh Gupta  AIIMS Delhi  Department of Dermatology and Venereology All India Institute of Medical Sciences ANSARI NAGAR NEW DELHI 110029 India
New Delhi
DELHI 
09868899120

someshgupta@aiims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N768||Other specified inflammation of vagina and vulva,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Reproductive age group (18-45 years) sexually active women attending the STD Clinic of Dermatology and Venereology and Obstetrics and Gynecology OPD will be enrolled in the study with prior informed consent 
 
ExclusionCriteria 
Details  Pre-menopausal, post-menopausal, pregnant or lactating women. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Development of a transvaginal probe-based dermatoscope  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. Development of an AI-enabled decision support system for diagnosis of vaginal and cervical pathologies using clinical images and patient metadata 2. Validation of the transvaginal probe-based dermatoscope with automated AI-enabled decision support against routine clinical management of STIs/RTIs in women  36 Months 
 
Target Sample Size   Total Sample Size="10000"
Sample Size from India="10000" 
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)   01/09/2025 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Women’s health is increasingly recognized as a critical public health issue. Gynecological exams are essential for sexual and reproductive health research, including screening for cervical cancer and infections. These exams typically involve external inspection, speculum examination, and bimanual palpation. However, they often cause discomfort due to pain, anxiety, and emotional distress, especially in prepubertal and post-menopausal women. Diagnosis of STIs/RTIs in many healthcare settings relies heavily on speculum-assisted visual inspection due to limited resources and a shortage of trained professionals. This often leads to inadequate care and over-reliance on syndromic management. To address these challenges, we propose developing a digital transvaginal dermatoscope with AI-enabled decision support for automated detection of vaginal and cervical pathologies. This innovation aims to provide a safe, non-traumatic, and accurate alternative to traditional gynecological exams, improving women’s healthcare significantly.

 
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