| CTRI Number |
CTRI/2025/03/081520 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| 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)= "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)
|
15/03/2025 |
| 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) |
Closed to Recruitment of Participants |
|
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
|
Aim : To assess potential of automated quantitative blood cell analyzer that combines innovative micro-nano technology and computer vision for blood analysis.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. |