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CTRI Number  CTRI/2024/10/074607 [Registered on: 01/10/2024] Trial Registered Prospectively
Last Modified On: 11/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Evaluation of HemoQR device against Gold Standard method for faster Anemia screening 
Scientific Title of Study   Evaluation (accuracy, sensitivity, reliability and concordance) of HemoQR device against Gold Standard method (Automated Hematology Analyzers) for Anemia Screening/Hemoglobin determination  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof. Suman Chakraborty  
Designation  Mechanical Engineering Department 
Affiliation  IIT Kharagpur  
Address  Micro fluidics labs, Mechanical Engineering Department, IIT Kharagpur

Medinipur
WEST BENGAL
721302
India 
Phone  9837402939  
Fax    
Email  suman@mech.iitkgp.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Suman Chakraborty 
Designation  Professor, Mechanical Engineering  
Affiliation  IIT Kharagpur  
Address  Micro fluidics labs, Mechanical Engineering Department, IIT Kharagpur


WEST BENGAL
721302
India 
Phone  9837402939  
Fax    
Email  suman@mech.iitkgp.ac.in  
 
Details of Contact Person
Public Query  
Name  Sohom Banerjee 
Designation  Project Manager 
Affiliation  IIT Kharagpur  
Address  Room No: NE 303, VSRC Old, CRTDH, IIT Kharagpur

Medinipur
WEST BENGAL
721302
India 
Phone  882051894  
Fax    
Email  sohom@mech.iitkgp.ac.in  
 
Source of Monetary or Material Support  
SmartQR Technologies PVT LTD M/s Smart QR Technologies Pvt. Ltd., Plot No.-65, Rishi House, Hindustan Estate Lane No.-13, Near Joggers Park, Kalyani Nagar, , Pune, Maharashtra (India) - 41100 
 
Primary Sponsor  
Name  SmartQR Technologies PVT LTD 
Address  M/s Smart QR Technologies Pvt. Ltd., A 205, Nagina CHS Ltd, Sani Shopping Centre,Jogeshwari West, Mumbai City, Maharashtra (India) - 411006 
Type of Sponsor  Other [Medical Devices Manufacturer] 
 
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 Shirin Dasgupta  B C Roy Technology Hospital  Senior Resident Dr B C Roy Multi Speciality Medical Research Centre
Medinipur
WEST BENGAL 		 8945973918

shirin@bcrmrc.iitkgp.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethical Committee - IIT Kharagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Outpatients of age group above 6 months attending the hematology laboratory for routine investigations, after taking prior written informed consent. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Outpatients of age group above 6 months attending the hematology laboratory for routine investigations, after taking prior written informed consent. 
 
ExclusionCriteria 
Details  Pregnant women, infants below the age of 6 months. Seriously ill patients known to suffer from bleeding diathesis 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Evaluate the diagnostic accuracy, sensitivity, reliability and concordance of HemoQR against Gold Standard method (Automated Hematology Analyzers) for Anemia Screening/Hemoglobin determination within a time frame of 7 days .The determination of feasibility and patient experience of the device by conducting a repeatability study to determine the consistency and precision of HemoQR results over multiple tests, ensuring its reliability for routine diagnostic and screening use.   The study can be completed within 7 days from the point of sample collection to result interpretation. 
 
Secondary Outcome  
Outcome  TimePoints 
Assess the analytical accuracy, sensitivity, reliability & concordance value of HemoQR against the gold standard methods of estimation of hemoglobin
for anemic & non-anemic patients
Conduct a comprehensive usability study, particularly targeting layman users, to assess the ease of use, user-friendliness, & effectiveness of the HemoQR system in real-world settings.
To implement a robust patient tracking system, utilizing the capabilities of the HemoQR mobile application, to monitor & manage patient data, ensuring seamless follow-up & continuity of care. 		 All the studies can be completed within a time frame of 1 week 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   15/10/2024 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Anemia which is one of world’s most prevalent nutritional disorder which affects 1/3rd of the global population. Hemoglobin monitoring is the most common biomarker for detecting anemia. About 50% population in India gets affected by anemia and have low Hemoglobin level. The impact of this can be fatal and increase mortality in children in the age bracket of 6- 59 months and also responsible for 20% maternal deaths. These data have been obtained from National Family Health Survey-5(NFHS-5) (2019-2021). Apart from anemia, hemoglobin levels can help in diagnosing other critical health problems like liver, kidney diseases, blood and other type of cancers, heart, and lungs conditions.
The novelty of HemoQR as compared to the Gold Standard method is that it provides a quick, economical, easy to use and premium hassle-free method for individuals to monitor their hemoglobin levels without usage of hemoglobinometer or any other commonly used biochemical and automated techniques thus reducing the cost dramatically and also making it cost effective and easy to use even for non-technical personnel thus helping to achieve mass screening in the remotest areas as well.
Our objectives are to validate the accuracy, sensitivity, reliability and concordance of our technology from the existing gold standard tests and also analyze the usability of the technology as a POC (point of care) solution and evaluate its efficiency and finally we will analyze the repeatability, consistency and precision of the results obtained from our technology in rural hospital/public health centre/medical college using fresh blood samples from 200 patients with equal male to female ratio.
Our methodology will revolve around participation selection, inclusion and exclusion criteria, duration of the study, procedure, data collection and analysis.
The expected outcome will be to determine hemoglobin level in the range of 3-18 gm/dl in the blood within a time period of less than 60 seconds. The system will also have autocalibration and minimal sample volume of not more than 30 μL will be used.
Anemia which is one of world’s most prevalent nutritional disorder which affects 1/3rd of the global population. Hemoglobin monitoring is the most common biomarker for detecting anemia. About 50% population in India gets affected by anemia and have low Hemoglobin level. The hemoglobin analysis is done using numerous methods which involves laboratory, analysers and POC like hemoglobinometers. Some of the popular methods are, cyanmethemoglobin method, automated hematology analyzers, hemoglobin electrophoresis, HemoCue method, colorimetric method, gas chromatography, spectrophotometric methods, hemoglobin color scale (HCS), reflectance photometry, portable hemoglobinometers, capillary blood sampling. HemoQR is a sensor technology which represents a significant advancement in Hemoglobin measurement in real time. The most important points of our HemoQR technology which makes its different from others are it will provide real time monitoring, high accuracy and precision and convenience and accessibility to wide range of the user. The working principle is based on digital image colorimetry using a mobile application only and thus removing the device dependency. The detection range of hemoglobin will be 3-18 gm/dl and the sample volume used will be 30 μL. This patented technology provides an easy to use, economical technique that utilizes smart phone-based reader to measure hemoglobin levels in the bloodstream. This makes it a perfect POC for the modern time which can auto calibrate and the data generated can be stored for a long time in the mobile app and on the server to monitor the change of hemoglobin with time without a paper print out. Its precision and reliability make it a promising tool in overall health management especially in detecting anemia and other critical health diseases. This technology will not only help in providing a quality of life but also it will help in decreasing infant and female mortality rates. The novelty of this technology is that it provides a quick, economical, easy to use and premium hassle-free method for individuals to monitor their hemoglobin levels
 
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