| CTRI Number |
CTRI/2024/02/062231 [Registered on: 02/02/2024] Trial Registered Prospectively |
| Last Modified On: |
01/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To explore the safety and performance of Extension Line & Needle Free Connector in Adult & Paediatric patients in Indian Population. |
|
Scientific Title of Study
|
A prospective, single arm, post market clinical follow-up of Extension Line & Needle Free Connector to explore safety and performance in Adult & Paediatric subjects in Indian Population. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RG/CRO/CIP (EXT-NFC), Version 3.0, Dated 01 June 2023. |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Kumar |
| Designation |
Senior Consultant |
| Affiliation |
The Medicity Hospital |
| Address |
Medicine Department Room No 6 Ground Floor The Medicity Hospital Teen Pani Kichha Road Rudrapur
Udham Singh Nagar
UTTARANCHAL
263153
India |
| Phone |
9868080947 |
| Fax |
|
| Email |
drsanjaymamc0078@zoho.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rohit Kumar |
| Designation |
Clinical Trial Assistant |
| Affiliation |
Romsons Group Private Limited |
| Address |
First Floor, Regulatory Department, Romsons Group Private Limited, 63-64, Industrial Estate, Nunhai
Agra
UTTAR PRADESH
282006
India |
| Phone |
8006599926 |
| Fax |
|
| Email |
cta2@romsons.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, Romsons Group Private Limited, 63-64, Industrial Estate, Nunhai
Agra
UTTAR PRADESH
282006
India |
| Phone |
9258105266 |
| Fax |
|
| Email |
regulatory2b@romsons.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 |
3-64, 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 Kumar |
The Medicity Hospital |
Teen Pani Kichha Road, Rudrapur
Udham Singh Nagar
UTTARANCHAL |
9868080947
drsanjaymamc0078@zoho.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for V3 Healthcare Private Limited |
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 |
| Intervention |
Exteena UNO (GS-3048 U), Exteena DUO (GS-3048 D),
Exteena TRIO (GS-3048 T),
Exteena QUADRO (GS-3048 Q),
Safsite (GS-3018)
|
Device maximum use duration is not more than 5 days |
| Comparator Agent |
NA |
NA |
|
|
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 Exteena IV extension line with needle free connector & Safsite IV needle free connector for attachment to IV line
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 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 LAR Legally Acceptable Representative who is willing and able to comply with the requirement of the follow-up |
|
| ExclusionCriteria |
| Details |
1 Subject present with medical emergency where treatment is more priority than the informed consent informed assent process
2 Subject having bleeding disorders condition where high pressure power injectors are used etc
3 Subject who cannot provide Informed Consent Form Adult such as unconscious mentally challenged subject OR in case of Paediatrics parent of child LAR Legally Acceptable Representative who cannot provide Informed Assent Form Child or give permission etc
4 Any known allergy with any of the material of Exteena IV extension line with needle free connector & Safsite IV needle free connector and its components
5 Other conditions which in the opinion of investigators make the subject unsuitable for enrolment or could interfere with his her participation in and completion of the clinical investigation plan
6 Subject who is pregnant or breast feeding
7 Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital
8 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 Intended for attachment to IV line
2 Facilitating vascular access for the continuous intermittent administration of drugs & solutions through needle free connector
3 IV Extension Line with female luer lock port having a flat swabable surface needle free connector with low prime volume
4 Fitment compatibility with all standard luer devices To use preferably with luer lock syringe
5 Swabable needle free connector surface ensures safe access
6 Improving the quality of life of the subject by achieving the intended clinical purpose |
Device maximum use duration is not more than 5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Secondary End Point of the study are as
1 Device material compatibility with the body tissue and fluids
2 Durability sustainability of device fitment with standard devices over required period of use |
Device maximum use duration is not more than 5 days |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/02/2024 |
| Date of Study Completion (India) |
22/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
This is a prospective, post marketing
clinical follow-up of Exteena (I.V. extension line with needle free connector)
& Safsite (I.V needle free connector) to explore the safety and performance
in subjects who are expected to require Exteena
(I.V Extension Line) & Safsite (I.V needle free connector) for attachment to I.V line with each
line having a slide clamp for selective closure & use for vascular access
during emergency resuscitation, Infusion therapy exchange transfusion, blood
sampling, administering antibiotic, etc. 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 Form/ Informed Assent Form 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. |