| CTRI Number |
CTRI/2024/01/061608 [Registered on: 18/01/2024] 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 safety and performance of device CVP (Central Venous Pressure) Manometer in Adult & Paediatric subjects in Indian population. |
|
Scientific Title of Study
|
A prospective, single arm, multi-centric, post market clinical follow-up of CVP Manometer 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 (CVPM), Version 3.0, Dated 01 June 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dheeraj Singh |
| Designation |
Consultant Cardiologist |
| Affiliation |
Atharva Multispecialty Hospital and Research Centre |
| Address |
Room No. 2, Basement, H-4/ comm-2, construction Div-21, UP Avas Vikas Parishad, IIM Road, Sector-E, Dubagga
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9311672757 |
| Fax |
|
| Email |
dr_dhiraj4u@yahoo.co.in |
|
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 |
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, 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 |
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 = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dheeraj Singh |
Atharva Multispeciality Hospital and Research Centre |
H-4, Comm-2, Construction Div-21, UP Avas Vikas Parishad, IIM Road, Sector-E, Dubagga
Lucknow
UTTAR PRADESH |
9311672757
dr_dhiraj4u@yahoo.co.in |
| Dr Md Wazir Rahman |
Tender Palm Hospital |
Sec-7, Gomti Nagar Extension, Amar Shaheed Path
Lucknow
UTTAR PRADESH |
8448824551
wzrrhmn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Independent Ethics Commitee Narayana Diagnostics |
Approved |
| Institutional Ethics Committee for Atharva Multispeciality Hospital and Research Centre |
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 |
CVP Manometer (GS-3008) |
Device maximum use duration is 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 Adult & Paediatric who are expected to require Central Venous Pressure monitoring assessment & monitoring of hemodynamics fluid status etc in critical medical conditions
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 who present with medical emergency where treatment is more priority than the informed consent informed assent process
2 Subject with severe conditions like Obstructed Vein Stenosis of the vein severe coagulopathy Traumatized site 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 CVP Manometer and its components
5 Other conditions which in the opinion of investigators make the subject unsuitable for enrolment or could interfere with the participation in and completion of the clinical investigation plan or protocol
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 Points of the study are as
1 For Central Venous Pressure monitoring
2 Facilitating continuous and intermittent monitoring of central venous pressure during short term infusion administration in ICU CCU OTs and casualty to monitoring fluid status in critical medical conditions
3 For continuous assessment of cardiac function circulating blood volume haemo-dynamics & patients response to the given treatment
4 Improving the Quality of life of the subject by achieving the intended purpose for Central Venous Pressure monitoring |
Device maximum use duration is not more than 5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Secondary End Points of the study are as
1 Durability Sustainability of device its fitment to the accessories with standard combination or connection devices required during the period of use
2 Materials Compatibility with the body fluids |
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)
|
30/01/2024 |
| Date of Study Completion (India) |
11/02/2025 |
| 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 CVP Manometer to explore safety and performance in subjects
who are expected to require continuous and intermittent monitoring of central
venous pressure during short term infusion administration in ICU, CCU, OTs,
casualty, emergency departments for continuous assessment of cardiac function,
circulating blood volume & subjects response to the given treatment. 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 / informed 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. |