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CTRI Number  CTRI/2025/12/098493 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On: 04/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Comparing a New Blood Monitoring Device with Standard Laboratory Tests 
Scientific Title of Study   Validation Study Comparing A Novel Non-Invasive Spectroscopic Device with Laboratory Methods for Measuring RBC, WBC, Platelets and Hemoglobin in Adult and Pediatric Patients A Prospective Observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vasudeva Bhat K 
Designation  Professor and Head 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Pediatric Oncology
Women and child block, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India 
Phone  9619114703  
Fax    
Email  vasudev.bhat@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Vasudeva Bhat K 
Designation  Professor and Head 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Pediatric Oncology
Women and child block, Kasturba Hospital, Manipal

KARNATAKA
576104
India 
Phone  9619114703  
Fax    
Email  vasudev.bhat@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Vasudeva Bhat K 
Designation  Professor and Head 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Pediatric Oncology
Women and child block, Kasturba Hospital, Manipal

KARNATAKA
576104
India 
Phone  9619114703  
Fax    
Email  vasudev.bhat@manipal.edu  
 
Source of Monetary or Material Support  
Vitritya Labs Pvt Ltd 
 
Primary Sponsor  
Name  Sriram R 
Address  No.235, 2nd and 3rd Floor, 13th Cross Road , Indira Nagar II stage , Hoysala Nagar, Indiranagar ( Bangalore), Bangalore, Bangalore North, Karnataka, India, 560038  
Type of Sponsor  Other [Private Lab] 
 
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 Vasudeva Bhat K  Kasturba Medical College, Manipal  Ground floor, Room No 1, Women and child block, Department of Pediatric Oncology, Kasturba Hospital, Manipal 576104
Udupi
KARNATAKA 		 7625032075

vasudev.bhat@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAHE Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  24.00 Month(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Paediatric patients aged 24 months to 17 years and adult patients aged 18 to 75 years.
Undergoing treatment that requires routine monitoring of blood parameters (e.g., chemotherapy, hematologic conditions).
Receiving care at participating hospital sites (inpatient or outpatient).
Able to provide informed consent (or assent with guardian consent for minors).
Willing to undergo non-invasive device based measurements during scheduled clinical visits
 
 
ExclusionCriteria 
Details  Severe cognitive or behavioural impairments that prevent cooperation during brief non invasive assessments.
Enrolment in another clinical study that may confound blood monitoring outcomes.
Individuals (or guardians, in case of minors) who decline to provide informed consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Concordance between device readings and laboratory CBC values
Accuracy across paediatric and adult groups
Usability and patient comfort (end of study questionnaire)
 		 0th, 1st and 2nd hour  
 
Secondary Outcome  
Outcome  TimePoints 
Feasibility of device for point-of-care monitoring
Suitability of data for AI-based trend prediction
Rate of successful usable readings
Completeness & consistency of collected data

 		 0th, 1st, 2nd hour  
 
Target Sample Size   Total Sample Size="142"
Sample Size from India="142" 
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)   01/01/2026 
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="1"
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  

This study aims to compare a new non invasive spectroscopic blood monitoring device with standard laboratory blood tests in adults and children who undergo routine CBC monitoring. During regular hospital visits, participants will have device readings performed alongside paired laboratory measurements. The study will evaluate how closely the device results match standard CBC values, as well as assess comfort, usability, and feasibility for clinical use. The findings will help determine whether this non-invasive device can support routine or point of care blood monitoring.

 
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