| CTRI Number |
CTRI/2024/02/063335 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To explore safety and performance of Blood Administration Set in Adult & Paediatric subjects in Indian Population. |
|
Scientific Title of Study
|
A prospective, single arm, post market clinical follow-up of Blood Administration Set to explore its safety and performance in Adult & Paediatric subjects in Indian Population. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RG/CRO/CIP (BAS), Version 3.0, Dated 01 June 2023. |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Kala |
| Designation |
Principal & Dean |
| Affiliation |
GSVM Medical College |
| Address |
Ground Floor department of General Surgery Principal office GSVM Medical College Swaroop Nagar
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
8726555577 |
| Fax |
|
| Email |
dr_sanjay_kala@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rohit Kumar |
| Designation |
Clinical Trial Assistant |
| Affiliation |
Romsons Group Private Limited |
| Address |
First Floor Regulatory Department 63-64 Industrial Estate Nunhai
Agra
UTTAR PRADESH
282006
India |
| Phone |
8006599926 |
| Fax |
|
| Email |
singhalrohit10000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anoop Batra |
| Designation |
Senior Manager- Regulatory Affairs |
| Affiliation |
Romsons Group Private Limited |
| Address |
First Floor Regulatory Department 63-64 Industrial Estate Nunhai
Agra
UTTAR PRADESH
282006
India |
| Phone |
9258105266 |
| Fax |
|
| Email |
anoopbatra2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Romsons Group Private Limited, 63-64, Industrial Estate, Nunhai, Agra-282006, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Romsons Group Private Limited |
| Address |
63-64, Industrial Estate, Nunhai, Agra |
| 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 Sanjay Kala |
G.S.V.M Medical College |
Ground Floor department of General Surgery Principal office GSVM Medical College Swaroop Nagar
Kanpur Nagar
UTTAR PRADESH |
8726555577
dr_sanjay_kala@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee GSVM Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
RMS Blood Administration Set SS-3052, Kwic Trans SS-3329, Ventra Fusion SS-3051, Blood Fusion SS-3317, Buretta for Blood SS-3096. |
Device maximum use duration is not more than 24 Hours. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Males and Females Adults & Paediatrics who are expected to require Blood Administration Set for intermittent or Continuous peripheral intravenous transfusion of blood and blood components.
2 Subject who can provide Informed Consent Form Adult in writing and medically in a position to undergo consent and screening process OR in case of Paediatrics parent of child or LAR Legally Acceptable Representative can provide Informed Assent Form Child.
3 The subject who is willing and able to comply with the requirement of the follow-up. OR in case of Paediatrics parent of child or LAR Legally Acceptable Representative who is willing and able to comply with the requirement of the follow-up. |
|
| ExclusionCriteria |
| Details |
1 Subject who present with medical emergency where treatment is more priority than the informed consent informed assent process.
2 Subject who cannot provide Informed Consent Form Adult such as unconscious mentally challenged subject OR in case of Paediatrics parent of child or LAR Legally Acceptable Representative who cannot provide Informed Assent Form Child or give permission etc.
3 Any known allergy with any of the material of Blood Administration Set and its components.
4 Other conditions which in the opinion of investigators make the patient unsuitable for enrolment or could interfere with his participation in and completion of the Clinical Investigation Plan or Protocol.
5 Subject who is pregnant or breastfeeding.
6 Participation in another research study involving an active investigation within 30 days prior to consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Primary End Point of the study are as
1 As Intended for continuous blood administration.
2 Facilitating Blood Administration from a container to a Patients peripheral vascular system through a needle or catheter.
3 To provide flow control or regulation while administering blood and blood products.
4 Improving the quality of life of the subject. |
Use duration of device is not more than 24 Hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Secondary End Point of the study are as
1 Durability sustainability & device fitment of the accessories with standard devices over required period of use.
2 Material Compatibility with the tissue & body Fluids. |
Use duration of device is not more than 24 Hours. |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
04/03/2024 |
| 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="0"
Months="6"
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
|
This is a
prospective, post marketing clinical follow-up of Blood Administration Set to explore
safety and performance in subject who requiring Blood Administration Set for intermittent
or Continuous peripheral intravenous transfusion of blood and blood components. Investigators and their team will be
responsible for recruitment and ethical conduct of the follow-up. As per
inclusion & exclusion criteria, subjects will be included in this follow-up.
An informed consent / assent will be obtained from all subjects who are
potential follow-up candidates prior to commencement of any follow-up related
procedure. All data will be
collected in the follow-up specific Case Report Form. |