| CTRI Number |
CTRI/2024/07/071199 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The hemoglobin data collection study by using Vivaray hb pro device developed by Bosch. |
|
Scientific Title of Study
|
A cross sectional, non-randomized clinical performance study to collect
the data using Vivaray Hb pro and use the device generated hemoglobin
value for validation by comparing it with the hemoglobin value
generated from the gold standard (calibrated blood cell counter). |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TI-V-Hb-P-2024-5/Version 1.0/Dated 09-May-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dipti Gupta |
| Designation |
Principal Investigator |
| Affiliation |
Dr. Diptis Multispecialty Clinics |
| Address |
Dr. Diptis Multispecialty Clinics, East Gokulpur Main Road, (Opposite M.C.D. Primary School), Delhi
East
DELHI
110094
India |
| Phone |
9811676049 |
| Fax |
- |
| Email |
drdipti16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Director Clinical Operations |
| Affiliation |
Tenet Health Edutech Pvt. Ltd. (Think-i) |
| Address |
602, 6th Floor, Tower B, KLJ NOIDA ONE Sector 62, Noida 201301, UP
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9971169602 |
| Fax |
- |
| Email |
dr.devesh.kumar@thinki.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Director Clinical Operations |
| Affiliation |
Tenet Health Edutech Pvt. Ltd. (Think-i) |
| Address |
602, 6th Floor, Tower B, KLJ NOIDA ONE Sector 62, Noida 201301, UP
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9971169602 |
| Fax |
- |
| Email |
dr.devesh.kumar@thinki.in |
|
|
Source of Monetary or Material Support
|
| Bosch Global Software Technologies Pvt. Ltd.
No. 123, Industrial Layout Hosur Road, Koramangala,560095,
Bangalore, Karnataka. |
|
|
Primary Sponsor
|
| Name |
Bosch Global Software Technologies Pvt. Ltd. |
| Address |
No. 123, Industrial Layout Hosur Road, Koramangala,560095,
Bangalore, Karnataka. |
| Type of Sponsor |
Other [Engineering Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ambanna Gowda |
Citizen Hospital |
Clinical Research Room, Ground Floor, New 14, 2nd Main Road, Kalasipalya Extn. Bangalore
Bangalore Bengaluru (Bangalore) Urban Karnataka -
560002 India
Bangalore
KARNATAKA |
9845270377
dr.ambanagowda@gmail.com |
| Dr Sunita Kapoor |
CITY X RAY AND SCAN CLINIC PVT LTD. |
Ground Floor, Clinical Reaserch Room, 5A/34, TILAK NAGAR, NEW DELHI-110018
West
DELHI |
8800999400
director@cityxrayclinic.com |
| Dr Dipti Gupta |
Dr. Diptis Multispeciality Clinics |
1st Floor, Clinical Research Room, East Gokulpur Main Road, (Opposite M.C.D. primary school)Delhi 110094.
East
DELHI |
9811676049
dr.dipti16@gmail.com |
| Dr Harsh Mittal |
Panchsheel Hospital |
Room no. B-1, Ground floor,
C-3/63A, 64A, opp. Gokulpuri police station, Block C, Yamuna Vihar, Shahdara, Delhi, 110053
North East
DELHI |
9560506410
-
harshmittal86@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Citizen Hospital Inst. Ethics Committee Citizen Wellness LLP |
Approved |
| GOOD SOCITY FOR ETHICAL RESEARCH GOOD SOCITY FOR ETHICAL RESEARCH |
Approved |
| Institutional Ethics Committee Panchsheel Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R799||Abnormal finding of blood chemistry, unspecified, (2) ICD-10 Condition: R799||Abnormal finding of blood chemistry, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or Female patients with age of greater than eight (8) years
2. Range of Hemoglobin 4-18 g/dl.
3. Able to give written informed consent, assent or parents’ consent form.
4. Finger size: 8 mm to 23 mm (The device is designed to fit fingers in this range) and index finger preferred to capture the signal.
|
|
| ExclusionCriteria |
| Details |
1. Patients with paronychia, fungal infections of the nail bed, blistering disorders involving the fingers, hyper-keratosis, nail polish, mehendi and callus formation on nail. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The objective of the study is to validate the clinical performance of Vivaray Hb pro
and use the device generated hemoglobin value for validation by comparing it with the hemoglobin value generated from the gold standard (calibrated blood cell counter).
|
Enrolment and Study Completion Visit – Visit 1
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="763"
Sample Size from India="763"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="765" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/08/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The World Health Organization classifies anemia as decrease in the number red blood cells or insufficient oxygen carrying capacity to meet the physiological needs, which varies by age, sex, altitude, smoking and pregnancy status. Deficiency in folate, vitamin-B12, vitamin-A, chronic inflammations, ulcers, pregnancy, parasitic infections, hemoglobinopathies, etc. can all lead to anemia, but iron-deficiency anemia is considered to be one of the leading causes of anemia in the world. It is advisable for hemoglobin (Hb) values to be continuously measured among people who undergo hemodialysis or suspected with anemia and oligocythemia (Kavsaoglu, Polat, & Hariharan, 2015). The purpose of this study to validate the clinical performance of Vivaray Hb pro and use the device generated hemoglobin value for validation by comparing it with the hemoglobin value generated from the gold standard (calibrated blood cell counter). |