| 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
|
|
|
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
|
|
|
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. |