| CTRI Number |
CTRI/2025/03/081520 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/09/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Open label |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison between CBC parameters obtained from medical device based on nano-technology and standard method. |
|
Scientific Title of Study
|
To assess potential of automated quantitative blood cell analyzer that combines
innovative micro-nano technology and computer vision for blood analysis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EBPL/2025/MD01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mugdha Ghag |
| Designation |
Consultant Pathologist |
| Affiliation |
Epigeneres Biotech Pvt.Ltd |
| Address |
Epigeneres Biotech Pvt. Ltd , Sun Mill Compound,Lower Parel , Mumbai
Mumbai
MAHARASHTRA
400013
India |
| Phone |
8698251316 |
| Fax |
|
| Email |
dr.mugdha@epigeneres.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mugdha Ghag |
| Designation |
Consultant Pathologist |
| Affiliation |
Epigeneres Biotech Pvt.Ltd |
| Address |
Epigeneres Biotech Pvt. Ltd , Sun Mill Compound,Lower Parel , Mumbai
MAHARASHTRA
400013
India |
| Phone |
8698251316 |
| Fax |
|
| Email |
dr.mugdha@epigeneres.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mugdha Ghag |
| Designation |
Consultant Pathologist |
| Affiliation |
Epigeneres Biotech Pvt.Ltd |
| Address |
Epigeneres Biotech Pvt. Ltd , Sun Mill Compound,Lower Parel , Mumbai
MAHARASHTRA
400013
India |
| Phone |
8698251316 |
| Fax |
|
| Email |
dr.mugdha@epigeneres.com |
|
|
Source of Monetary or Material Support
|
| Epigeneres Biotech Pvt.Ltd , 1st Floor , Todi Building , Mathuradas Mill Compound , Senapati Bapat Marg , Lower Parel , Mumbai - 400013 |
|
|
Primary Sponsor
|
| Name |
Epigeneres Biotech Pvt.Ltd |
| Address |
Epigeneres Biotech Pvt.Ltd , 1st Floor , Todi Building , Mathuradas Mill Compound , Senapati Bapat Marg , Lower Parel , Mumbai - 400013 |
| Type of Sponsor |
Other [Biotechnology Company ] |
|
|
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 Mugdha Ghag |
Epigeneres Biotech Pvt.Ltd |
Research Department,Ikon House,B Block, Sun Mill Compound,Lower Parel , Mumbai 400013
Mumbai
MAHARASHTRA |
08698251316
dr.mugdha@epigeneres.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| V-Care Independent Ethics Committee |
Approved |
| V-Care Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age: 18-90 years, irrespective of clinical history
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1. Age: 18-90 years, irrespective of clinical history
2. Subjects who are able to understand and willing to sign the informed consent form (ICF)
3. Subjects who are willing and able to comply with scheduled visit. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. Age less than 18 years.
2. Subject suffering from Immune thrombocytopenic
purpura (ITP)
3. Subjects on cytotoxic drugs
4. Verified biohazard samples will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Assessment of potential of iMOST-L analyzer for the quantitative measurement of blood count (CBC) parameters.
2.Accuracy of the device determined by comparing device generated data with standard blood testing method .
3.Specificity and sensitivity of the iMOST-L analyzer determined by comparing results obtained from peripheral blood and fingertip blood analysis . |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2025 |
| Date of Study Completion (India) |
11/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
Modification(s)
|
Title: To assess potential of automated quantitative blood cell analyzer
that combines innovative micro-nano technology and computer vision for blood
analysis.
Protocol ID: EBPL/2025/MD01
, Version no: 1.1 Date:
03-10-2025
PI: Dr. Mugdha
Ghag, Co-PI: Dr. Kshama
Pansare
Study Site and Study Sponsor: Tzar Genomics India Private Limited.
Milestone to be achieved : To assess potential of iMOST-L
analyzer for the quantitative measurement of complete blood count (CBC)
parameters.
Study Design : 5 ml of blood sample will be collected from all
eligible subjects for the study.
Objectives :
1. To assess potential of iMOST-L analyzer for the quantitative
measurement of complete blood count (CBC) parameters.
2. To determine accuracy of the device by comparing data obtained
from device with data obtained from standard blood testing method.
3. To
determine specificity and sensitivity of the iMOST-L analyzer by comparing
results obtained from peripheral blood analysis with fingertip blood analysis.
Study Closure
Report Summary
|
1.
|
Date of First
EC Approval
|
10-02-2025
|
|
2.
|
No. of Amendments
|
1
|
|
3.
|
Date of Last
EC Approval
|
10-11-2025
|
|
4.
|
Date of First Enrollment
|
01-04-2025
|
|
5.
|
Date of Last Enrollment
|
11- 06-
2025
|
|
6.
|
Total Subjects Enrolled
|
100
|
|
7.
|
Total Withdrawals
|
0
|
|
8.
|
Reason for Withdrawals
|
NA
|
|
9.
|
Any Adverse Events Reported
|
NO
|
Is this an early termination of study: No
Reason for study closure: Enrolment completed as per protocol, study
data have been analyzed and the final study report has been completed.
Therefore, the study is being closed.
All the study documents
including informed consent form and case report form are assessed for completeness
and accuracy. The documents are compliant with ICH – GCP guideline.
Conclusion: The present study demonstrated that the iMOST-L Analyzer provides
accurate and clinically reliable quantitative measurement of 12 CBC parameters.
Results obtained from the iMOST-L
analyzer showed clinically acceptable agreement with the reference Horiba
Yumizen H550 hematology analyzer.
Presentations & publications associated with this study: Currently, None |