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CTRI Number  CTRI/2025/02/081416 [Registered on: 27/02/2025] Trial Registered Prospectively
Last Modified On: 24/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Diagnostic performance of an AI program in detecting Group A Streptococcal Pharyngitis via smartphone-acquired images , to determine the diagnostic performance of an AI algorithm in evaluating pharyngitis using images acquired with a smartphone in a live pediatric clinical setting. 
Scientific Title of Study   Diagnostic performance of an AI program in detecting Group A Streptococcal Pharyngitis via smartphone-acquired images 
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 Mandyam Dhati Ravi 
Designation  Pediatrician and Chief Coordinator 
Affiliation  JSS HOSPITAL 
Address  Department of Center for Clinical Research Excellence 2nd Floor Room No 2222 JSS HOSPITAL M G Road Mysuru
Department of Center for Clinical Research Excellence 2nd Floor Room No 2222 JSS HOSPITAL M G Road Mysuru
Mysore
KARNATAKA
570004
India 
Phone  9880629506  
Fax  08212335556  
Email  mandyamdhatiravi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mandyam Dhati Ravi 
Designation  Pediatrician and Chief Coordinator 
Affiliation  JSS HOSPITAL 
Address  Department of Center for Clinical Research Excellence 2nd Floor Room No 2222 JSS HOSPITAL M G Road Mysuru
Department of Center for Clinical Research Excellence 2nd Floor Room No 2222 JSS HOSPITAL M G Road Mysuru
Mysore
KARNATAKA
570004
India 
Phone  9880629506  
Fax  08212335556  
Email  mandyamdhatiravi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vinaya Rani G  
Designation  Project manager 
Affiliation  JSS Academy of Higher Education and Research , JSS HOSPITAL 
Address  Department of Center for Clinical Research Excellence 2nd Floor Room No 2222 JSS HOSPITAL M G Road Mysuru
Department of Center for Clinical Research Excellence 2nd Floor Room No 2222 JSS HOSPITAL M G Road Mysuru
Mysore
KARNATAKA
570004
India 
Phone  7204439185  
Fax  08212335556  
Email  vinayagowd@gmail.com  
 
Source of Monetary or Material Support  
Dr James Lee CEO Little Angel Medical 9375-5668  
 
Primary Sponsor  
Name  Little Angel Medical  
Address  Dr James Lee CEO Little Angel Medical 9375-5668 Québec INC. 
Type of Sponsor  Other [ AI-powered technology based app developer] 
 
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 MANDYAM DHATI RAVI  JSS HOSPITAL   Center for Clinical Research Excellence 2nd Floor Room No 2222 JSS HOSPITAL M G Road Mysuru
Mysore
KARNATAKA 
9880629506

mandyamdhatiravi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee JSS Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J020||Streptococcal pharyngitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  The study will include all 3-11year-old children presenting to the Montreal Children’s
Hospital Emergency Department with complaints of sore throat that fit the inclusion criteria
listed above. A Student Investigator (SI) or Research Assistant (RA) (trained in the use of Siurge)
will recruit patients meeting the inclusion criteria and obtain signed informed consent from the
parent/guardian. ED staff will not be required to assist in the obtention of any information.
Patients eligible for 
 
ExclusionCriteria 
Details  Participant parents who are not willing to give consent  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Can an AI algorithm detect pharyngitis in a pediatric clinical setting using
images of the oropharynx acquired by a smartphone? 
9 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Outcomes: Sensitivity, specificity, area under the Receiver Operating Characteristic curve
[AUROC] and under the precision-recall curve [AUPRC], weighted F1 score, confusion matrices
of true and false classifications, diagnostic odds ratio, diagnostic effectiveness, and likelihood
ratios (+/-). 
NA 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   24/03/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

The study will include all 3-11year-old children presenting to the JSS Hospital Emergency Department (ED) and associated departments with complaints of sore throat that fit the inclusion criteria listed above. Principal investigator (PI) or Research Assistant (RA) will recruit patients meeting the inclusion criteria and obtain signed informed consent from the parent/guardian. ED staff will not be required to assist in the obtention of any information. Patients eligible for


participation in the study will be preliminarily identified based on information disclosed during triage upon presentation, followed by full eligibility verification (by the PI or RA) based on information provided by the parent. Recruitment will take place as eligible patients are waiting for physician evaluation. All subjects will be evaluated and screened for study eligibility by the research team prior to study entry. This is a convenience sample of children with pharyngitis; the subjects will be enrolled when a member of the research team is present in the ED. Patient data (name, age, sex, relevant clinical history) will be uploaded into a mobile application by the PI or RA. The identifying information, such as names and dates of birth, of study participants will be omitted from the data library once data collection is complete. The application will consist of a patient input screen, followed by a series of clinical data prompts. Next, a video capture screen where the PI or RA will capture a 3-5 second video of the patients’ throat using the built-in iPhone camera as per recommended steps for video acquisition (see Appendix A.Taking Throat Images with a Smartphone). The treating physician will be blinded to the video take by the PI or RA until they have examined the patient independently. When necessary, a tongue depressor will be used to better visualize the throat.


 
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