| CTRI Number |
CTRI/2025/07/091408 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of the AS76 with PBS device for Peripheral Blood Smear Examination. |
|
Scientific Title of Study
|
Clinical Evaluation of AS76 with PBS versus light microscopy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tathagato Rai Dastidar |
| Designation |
CEO |
| Affiliation |
Sigtuple Technologies Private Limited |
| Address |
SigTuple Technologies Pvt Ltd
L-162 14th Cross Road 6th Sector HSR Layout Bangalore
560102 INDIA
Bangalore
KARNATAKA
560102
India |
| Phone |
9036839020 |
| Fax |
|
| Email |
trd@sigtuple.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tathagato Rai Dastidar |
| Designation |
CEO |
| Affiliation |
Sigtuple Technologies Private Limited |
| Address |
SigTuple Technologies Pvt Ltd
L-162 14th Cross Road 6th Sector HSR Layout Bangalore
560102 INDIA
Bangalore
KARNATAKA
560102
India |
| Phone |
9036839020 |
| Fax |
|
| Email |
trd@sigtuple.com |
|
Details of Contact Person
Public Query
|
| Name |
Tathagato Rai Dastidar |
| Designation |
CEO |
| Affiliation |
Sigtuple Technologies Private Limited |
| Address |
SigTuple Technologies Pvt Ltd
L-162 14th Cross Road 6th Sector HSR Layout Bangalore
560102 INDIA
Bangalore
KARNATAKA
560102
India |
| Phone |
9036839020 |
| Fax |
|
| Email |
trd@sigtuple.com |
|
|
Source of Monetary or Material Support
|
| SigTuple Technologies Private Limited,
L-162 14th Cross Rd, Sector 6,
HSR Layout Bengaluru ( Bangalore)
Karnataka 560102 India |
|
|
Primary Sponsor
|
| Name |
SigTuple Technologies Pvt Ltd |
| Address |
SigTuple Technologies Pvt Ltd
L-162 14th Cross Road 6th Sector HSR Layout Bangalore
560102 INDIA
|
| Type of Sponsor |
Other [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 Jayaprakash C S |
Father Muller Medical College |
Central Laboratory Department of Pathology Father Muller Research Center Father Muller Road Kankanady Mangalore 575002 Karnataka India
Dakshina Kannada
KARNATAKA |
08242238327
csjayaprakash@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee (FMIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R70-R79||Abnormal findings on examination of blood, without diagnosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
The study is an “all comers” study that shall include samples from healthy individuals and samples from individuals with various hematological conditions and distributional abnormalities such as anemia, thrombocytopenia, leukopenia, leukocytosis, elevated hematocrit, elevated nucleated red blood cells, leukemia, etc.
The abnormal samples shall align with the recommendations of the CLSI H20-A2 standard. Samples from both genders shall be used. Samples from individuals belonging to any race/ethnicity can be used. |
|
| ExclusionCriteria |
| Details |
The following sample exclusion criteria shall be applied -
1. Slides that are not prepared adequately shall be excluded from the study. For example – slides that are
not smeared well or are stained poorly.
2. Slides that have been prepared from degenerated blood and are considered unsuitable for evaluation
by the qualified reviewers after examination under a light microscope (as per the standard procedures
of the laboratory).
3. Slides considered unsuitable for evaluation by the qualified reviewers after examination under light
microscope (as per the laboratory’s standard procedures). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Agreement between AS76 with PBS and light microscopy in evaluating white blood cell (WBC), red blood cell (RBC), and platelet (PLT) morphologies. For WBCs: Passing-Bablok regression (slope, intercept, bias) will be used for differential counts. Sensitivity, specificity, and overall agreement will be calculated for detecting WBC abnormalities. For RBCs and PLTs: sensitivity, specificity, and overall agreement for morphological abnormalities.
|
The outcomes will be analyzed 3 months from the date of study initiation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
04/08/2025 |
| 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)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
The AS76 with PBS device is an automated cell-locating device intended for 1.Quantitative analysis of WBC (Differential count of white blood cell types) 2.Semi-quantitative analysis of RBC (Morphological analysis of red blood cells) 3.Quantitative (Estimation of Platelet count) and Semi-quantitative analysis of platelets (Morphological analysis of Platelets). Study Objective The objective of this study is to evaluate the clinical performance of the AS76 with PBS system using peripheral blood smear (hereafter referred to as PBS) and establish equivalence with the reference method, manual review under a light microscope Study Endpoint The endpoint of the study is the comparison of operator-classified results of White Blood Cell (WBC) morphologies, Red Blood Cell (RBC) morphologies and Platelet (PLT) morphologies against manual microscopy using multiple statistical measures. |