| CTRI Number |
CTRI/2024/03/064212 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [medical device performance evaluation validation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on Evaluating the performance of the medical device ADVIA 2120i Hematology analyser |
|
Scientific Title of Study
|
Performance Qualification of ADVIA 2120i Hematology analyser |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.R C Satish Kumar |
| Designation |
Co-ordinator |
| Affiliation |
SRM Institute of science and Technology, Interdisciplinary Institute of Indian system of Medicine |
| Address |
Room No.18,B-4,4th floor, Clinical trial Unit,SRM Medical College Hospital And Research Centre SRM Nagar Potheri,Chengalpattu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884845997 |
| Fax |
|
| Email |
ayursatish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.R C Satish Kumar |
| Designation |
Co-ordinator |
| Affiliation |
SRM Institute of Science and technoogy, Interdisciplinary Institute of Indian system of Medicine |
| Address |
Room No.18,B-4,4th floor, Clinical trial Unit,SRM Medical College Hospital And Research Centre SRM Nagar Potheri,Chengalpattu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884845997 |
| Fax |
|
| Email |
ayursatish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.B.Mothish waran |
| Designation |
Clinical Research Associate |
| Affiliation |
SRM Institute of Science and Technology, Interdisciplinary Institute of Indian system of Medicine |
| Address |
Room No.18,B-4,4th floor, Clinical trial Unit,SRM Medical College Hospital And Research Centre SRM Nagar Potheri,Chengalpattu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8825580604 |
| Fax |
|
| Email |
mothishwaran26@gmail.com |
|
|
Source of Monetary or Material Support
|
| HCL Technologies, No. 602/3 Elcot Economic Zone, Medavakkam High Road, Sholinganallur, Chennai. |
|
|
Primary Sponsor
|
| Name |
HCL Technologies |
| Address |
No. 602/3 Elcot Economic Zone, Medavakkam High Road, Sholinganallur, Chennai. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 RC satish kumar |
SRM medical college hospital and research centre |
Room No.18,B-4,4th floor, Clinical trial Unit,SRM Medical College Hospital And Research Centre SRM Nagar Potheri,Chengalpattu
Kancheepuram
TAMIL NADU |
9884845997
ayursatish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MCH & RC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Partcipants to be in good health, as determined by health evaluation.
Participants agree to provide informed consent. |
|
| ExclusionCriteria |
| Details |
Participants with any significant medical condition.
Participants with abnormal laboratory results.
Participants with concomitant medication.
Partcipants with above 45 years of age.
Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
to assess the performance and calibrate the ADVIA 2120i
Analyzer system The parameters that are assesed RBC , WBC ,Platelets, Neutrophils,Eosinophils,Basophils,Monocytes,Lymphocytes, RDW,MCH,MCHC and haemoglobin |
to assess the performance and calibrate the ADVIA 2120i
Analyzer system at day 30. The parameters that are assesed RBC , WBC ,Platelets, Neutrophils,Eosinophils,Basophils,Monocytes,Lymphocytes, RDW,MCH,MCHC and haemoglobin |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The successful performance qualification of the ADVIA 2120i Analyzer enables to
perform the design verification with respect to hardware & software engineering changes. The parameters that are assesed RBC , WBC ,Platelets, Neutrophils,Eosinophils,Basophils,Monocytes,Lymphocytes, RDW,MCH,MCHC & haemoglobin after 30 days |
The successful performance qualification of the ADVIA 2120i Analyzer enables to
perform the design verification with respect to hardware & software engineering changes at end of the study The parameters that are assesed RBC , WBC ,Platelets, Neutrophils,Eosinophils,Basophils,Monocytes,Lymphocytes, RDW,MCH,MCHC & haemoglobin after 30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
26/03/2024 |
| 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) |
Open to Recruitment |
|
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
|
This study is motivated by the need to maintain the accuracy and precision of the ADVIA 2120i
Hematology Analyzer when analyzing fresh whole blood samples. It plays a crucial role in quality
control and ensuring that the instrument remains fit for clinical use. The involvement of HCL
technical staff, well-versed in verification and validation methods, and trained in haematology
analyzers, guarantees the meticulous handling of biological samples and adherence to Good
Clinical Laboratory practices and biomedical waste management protocols. this study plays a pivotal role in ensuring the performance and reliability of the
ADVIA 2120i Hematology Analyzer, which has far-reaching implications for the field of clinical
hematology and diagnostics |