| CTRI Number |
CTRI/2026/01/102472 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Mobile application for image based white blood cell analysis |
|
Scientific Title of Study
|
Comprehensive hematology companion blood cell budy,a differential counter app with advanced image based |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swetha P |
| Designation |
Post graduate |
| Affiliation |
Saveetha medical college and hospital, Saveetha institute of medical and technical sciences. |
| Address |
5th floor, Hospital building, Department of pathology, Saveetha medical college and hospital, Saveetha institute of medical and technical sciences, Saveetha nagar, Thandalam, Chennai, India
Chennai TAMIL NADU 602105 India |
| Phone |
8220445482 |
| Fax |
|
| Email |
spswethu@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Volga H |
| Designation |
Professor |
| Affiliation |
Saveetha medical college and hospital, Saveetha institute of medical and technical sciences. |
| Address |
5th floor, Hospital building, Department of pathology, Saveetha medical college and hospital, Saveetha institute of medical and technical sciences, Saveetha nagar, Thandalam, Chennai, India
Chennai TAMIL NADU 602105 India |
| Phone |
9677342029 |
| Fax |
|
| Email |
drhsvol@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Swetha P |
| Designation |
Post graduate |
| Affiliation |
Saveetha medical college and hospital, Saveetha institute of medical and technical sciences. |
| Address |
5th floor, Hospital building, Department of pathology, Saveetha medical college and hospital, Saveetha institute of medical and technical sciences, Saveetha nagar, Thandalam, Chennai, India
Chennai TAMIL NADU 602105 India |
| Phone |
8220445482 |
| Fax |
|
| Email |
spswethu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai-602105 |
|
|
Primary Sponsor
|
| Name |
Dr. Swetha. P |
| Address |
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai-602105 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Swetha P |
Saveetha Medical College Hospital |
5th floor, Hospital building, Department of Pathology, Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai Chennai TAMIL NADU |
8220445482
spswethu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Population criteria- Patients with various hematological derangements who undergo peripheral smear examination.
2. Medical history- Patients with a history of fever or clinical evidence of infection who undergo blood smear examination.
3. CBC Data: Patients with abnormal white blood cell distribution in automated analyzers.
4. Ethnicity and demographics: Consideration of diverse ethnic and demographic backgrounds to ensure the generalizability of the predictive model. |
|
| ExclusionCriteria |
| Details |
1. Newborns: Excluding newborns to eliminate misdiagnosis due to the presence of nucleated red blood cells that may mimic white blood cells.
2. Lysed blood samples: Excluding patients whose samples are lysed because cells are not visualized adequately on the blood smear.
3. Inadequate clinical and lab data: Patients with inadequate clinical data are excluded, as there is no grounds to decide whether blood smear examination is warranted.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To calculate the differential count of each type of white blood cell using AI based image analysis of the uploaded images of microscopic fields in the blood smear |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To calculate the accuracy and clinical utility of the AI model by correlating with manual differential counts. |
1 week |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
03/02/2026 |
| 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="6" 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
|
Blood Cell Buddy is a mobile application designed to make white blood cell differentiation faster, more standardized, and less prone to observer variation. It works by allowing users to upload or capture microscopic images of peripheral blood smears, after which the app analyzes the image and identifies various white blood cell types such as neutrophils, lymphocytes, monocytes, eosinophils, and basophils. The algorithm uses image-based morphometric features like nuclear shape, cytoplasmic color, and granularity to distinguish between cell types. The app is structured so that a trained AI model can easily be integrated later for real diagnostic analysis. When powered by a well-trained convolutional neural network, the system can achieve accuracy levels comparable to human experts, typically exceeding 90 percent in test conditions using standardized datasets. Clinically, this tool serves as a rapid screening aid rather than a definitive diagnostic device. It can help laboratories and clinicians perform preliminary differentials in resource-limited settings, educational demonstrations, or as a cross-check to manual counts. The automated nature of the analysis minimizes fatigue-related errors, increases reproducibility, and accelerates workflow. By combining user-friendly interface design with future AI integration potential, the app aims to bridge the gap between manual microscopy and digital hematology, offering a reliable, accessible, and scalable approach to WBC differential counting. |