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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  
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 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  
Status 
Not Applicable 
 
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.

 
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