| CTRI Number |
CTRI/2026/02/104847 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Screening |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Testing the accuracy of the Helo-HB Digital Hemoglobinometer compared to gold standard laboratory methods at Shrimad Rajchandra Hospital |
|
Scientific Title of Study
|
Clinical Validation of HELO HB Point-of-Care Digital Hemoglobinometer Compared with Automated Hematology Analyzer (Sysmex/Erba) at Shrimad Rajchandra Hospital and Research Centre, Dharampur |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SRHRC-HELOHB-VAL-2026-01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gaurij Hood |
| Designation |
Consultant Public Health Specialist and Senior Advisor |
| Affiliation |
Shrimad Rajchandra Hospital and Research Centre |
| Address |
Sample Collection Room, Ground floor, Shrimad Rajchandra Hospital and Research Centre, Bypass Road, Dharampur, Valsad
Sample Collection Room, Ground floor, Shrimad Rajchandra Hospital and Research Centre, Bypass Road, Dharampur, Valsad
Valsad
GUJARAT
396050
India |
| Phone |
9673879921 |
| Fax |
|
| Email |
clinicalresearch@hospital.srmd.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurij Hood |
| Designation |
Consultant Public Health Specialist and Senior Advisor |
| Affiliation |
Shrimad Rajchandra Hospital and Research Centre |
| Address |
Shrimad Rajchandra Hospital and Research Centre, Bypass road, Dharampur, Valsad
Sample collection room, Ground floor, Shrimad Rajchandra Hospital and Research Centre, Bypass road, Dharampur, Valsad
Valsad
GUJARAT
396001
India |
| Phone |
9673879921 |
| Fax |
|
| Email |
clinicalresearch@hospital.srmd.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurij Hood |
| Designation |
Consultant Public Health Specialist and Senior Advisor |
| Affiliation |
Shrimad Rajchandra Hospital and Research Centre |
| Address |
Shrimad Rajchandra Hospital and Research Centre, Bypass road, Dharampur, Valsad
Sample collection room, ground floor, Shrimad Rajchandra Hospital and Research Centre, Bypass road, Dharampur, Valsad
Valsad
GUJARAT
396001
India |
| Phone |
9673879921 |
| Fax |
|
| Email |
clinicalresearch@hospital.srmd.org |
|
|
Source of Monetary or Material Support
|
| Adarsa Private Limited,
Unit no. 308, United Business Park, Road number 11, near old Passport Office, Ambika Nagar no. 3, Thane west, Thane, Maharashtra (400604) |
|
|
Primary Sponsor
|
| Name |
Adarsa Private Limited |
| Address |
Adarsa Private Limited
Unit No. 308, United Business Park, Road Number 11, near Old Passport Office, Ambika Nagar No 3, Thane West, Thane, Maharashtra 400604 |
| Type of Sponsor |
Other [MD and IVD Medical Device Manufacturer] |
|
|
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 Gaurij Hood |
Shrimad Rajchandra Hospital and Research Centre |
Shrimad Rajchandra Hospital and Research Centre, Bypass road, Dharampur, Valsad, Gujarat (396050)
Valsad
GUJARAT |
96738 79921
clinicalresearch@hospital.srmd.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shrimad Rajchandra Hospital and Reserach Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z000||Encounter for general adult medical examination, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Automated Hematology Analyzer (Sysmex or Erba) |
Hemoglobin estimation using standard automated hematology analyzer (Sysmex or Erba) from the same venous blood sample will be used as the reference method for comparison. |
| Intervention |
Helo HB |
Hemoglobin estimation using HELO HB point of care digital hemoglobinometer will be performed from the same venous blood sample at the time of routine CBC testing as per manufacturer instructions. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of any age and gender undergoing CBC testing
2. Patients (or legal guardians) providing written informed consent |
|
| ExclusionCriteria |
| Details |
1. Refusal to provide consent
2. Hemolyzed or clotted blood samples
3. Any condition precluding safe sample collection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy (bias) of hemoglobin values obtained using HEL |
For completion of 500 tests for comparision, we would need about 3-6 months duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation, agreement (Bland–Altman), sensitivity, specificity, performance across Hb ranges & age groups, & operator usability - all assessed at the time of sample testing. |
For completion of 500 tests for comparison, we would need about 3-6 months duration |
|
|
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)
|
09/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
09/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [clinicalresearch@hospital.srmd.org].
- For how long will this data be available start date provided 01-07-2026 and end date provided 01-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to clinically validate the performance of the HELO HB point of care digital hemoglobinometer by comparing hemoglobin measurements obtained from the device with those obtained from an automated hematology analyzer among patients undergoing routine complete blood count testing at Shrimad Rajchandra Hospital and Research Centre Dharampur. The study will be a hospital based cross sectional comparative analytical study including approximately 500 participants across different age groups and hemoglobin ranges. From the same venous blood sample hemoglobin estimation will be performed using both the HELO HB device and the laboratory analyzer without collecting any additional blood exclusively for research purposes. The study will evaluate accuracy correlation agreement sensitivity and specificity of the device and assess its usability for routine clinical use and mass screening programs. The findings are expected to provide evidence regarding the reliability and clinical applicability of the HELO HB device for rapid hemoglobin estimation in hospital and community healthcare settings. |