| 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
|
|
|
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
|
|
|
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.
|