| CTRI Number |
CTRI/2021/09/036597 [Registered on: 17/09/2021] Trial Registered Prospectively |
| Last Modified On: |
16/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Study to evaluate safety and performance of Acent Central Venous Catheter in patients requiring central venous catheterization. |
|
Scientific Title of Study
|
Central venous Catheter: A prospective, open label, multi-centre, single arm, observational, post marketing clinical follow-up study to evaluate safety and performance of Acent Central Venous Catheter in patients requiring central venous catheterization during routine clinical practice. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EUP-GML-21-003, Version 1.0 dated 08-Jul-2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jatin Soni |
| Designation |
Head- Clinical Operations & Project Management |
| Affiliation |
Eupraxia Centre For Clinical Excellence LLP |
| Address |
205, Spentha Complex,
Race Course, Opposite Pizza Hut,
Vadodara-390007, Gujarat, India
Vadodara
GUJARAT
390007
India |
| Phone |
9630635333 |
| Fax |
|
| Email |
jsoni@eupraxiaconsulting.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jatin Soni |
| Designation |
Head- Clinical Operations & Project Management |
| Affiliation |
Eupraxia Centre For Clinical Excellence LLP |
| Address |
205, Spentha Complex,
Race Course, Opposite Pizza Hut,
Vadodara-390007, Gujarat, India
GUJARAT
390007
India |
| Phone |
9630635333 |
| Fax |
|
| Email |
jsoni@eupraxiaconsulting.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jatin Soni |
| Designation |
Head- Clinical Operations & Project Management |
| Affiliation |
Eupraxia Centre For Clinical Excellence LLP |
| Address |
205, Spentha Complex,
Race Course, Opposite Pizza Hut,
Vadodara-390007, Gujarat, India
GUJARAT
390007
India |
| Phone |
9630635333 |
| Fax |
|
| Email |
jsoni@eupraxiaconsulting.com |
|
|
Source of Monetary or Material Support
|
| Global Medikit Ltd., Dr. G.C. Narang Marg, Cavalry Rd,
New Delhi – 110 007, India
|
|
|
Primary Sponsor
|
| Name |
Global Medikit Ltd |
| Address |
Dr. G.C. Narang Marg, Cavalry Rd,
New Delhi – 110 007, India
|
| Type of Sponsor |
Other [Medical device manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashpak Bangi |
BAJ RR Hospital |
P-14, Phase-I,Milap Nagar, Dombivli(E) Dist.Thane, Maharashtra-421203, India
Thane
MAHARASHTRA |
9820576741
nandadrpreeti@gmail.com |
| Dr Ashpak Bangi |
Jivanrekha Multispecialty Hospital |
Sr.28, Prabhu Complex,
Old Mumbai - Pune Hwy,
opposite to Republic School, Pune,
Maharashtra 412101, India
Pune
MAHARASHTRA |
7972700600
drashpakresearch@gmail.com |
| Dr Sonia Naik |
Shree Ashirwad Hospital |
C/3 Shree complex, Opposite Mahavir Nagar, Manpada Road Dombivali(E) 421201, Mumbai, india
Mumbai
MAHARASHTRA |
9930480526
naik.sonia2002@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Altezza Institutional Ethics Committee |
Submittted/Under Review |
| Altezza Institutional Ethics Committee |
Approved |
| Jivanrekha Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z452||Encounter for adjustment and management of vascular access device, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acent-1, 2 & 3 – Central venous catheter (CVC) (Single, Double & Triple Lumen, Seldinger technique) |
Dose: NA,
Frequency: NA,
Route of administration: As per standard of care,
Duration of therapy: As per standard of care.
|
| Comparator Agent |
NA |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient aged ≥18 at the time of enrolment
2. Patient who receive Acent-1/2/3 CVC using Seldinger technique as per the instruction mentioned in instructions for use (IFU) of the study device during routine clinical practice as per the discretion of investigator/treating physician
3. Patient or his/her legally authorized representative (if applicable) agrees to provide written informed consent
4. Patient is willing to comply with clinical investigation plan (CIP) specified follow-up evaluations
|
|
| ExclusionCriteria |
| Details |
1. Patient with contraindications for catheterization with CVC mentioned in the IFU of study device
2. Patient with a history of thrombocytopenia
3. Patient with a history of bleeding disorders
4. infection signs, wounds and subcutaneous haematoma close to the puncture site
5. Currently participating in another clinical study with experimental drugs or devices
6. Active SARS-CoV-2 infection known to patient at the time of enrolment in the study/ patients having signs and symptoms of SARS-CoV-2 infection at the time of enrolment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of this study is to evaluate the complications associated (safety) with Acent CVC (Seldinger technique) during and post catheterization in patients requiring short term central venous catheterization. |
time points would be at the day of surgery and on the day of catheter removal (As per SOC) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objective is to evaluate performance of Acent CVC (Seldinger technique) in patients requiring short term central venous catheterization. |
At the day of surgery |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
20/09/2021 |
| 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
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prospective, open label, multi-centre, single arm, observational,
post marketing clinical follow-up study to evaluate safety and performance of
Acent Central Venous Catheter in patients requiring central venous
catheterization during routine clinical practice.
Primary objective: The primary objective of this study is to evaluate the
complications associated (safety) with Acent CVC (Seldinger technique) during
and post catheterization in patients requiring short term central venous
catheterization. Secondary objective: The secondary objective is to evaluate performance of
Acent CVC (Seldinger technique) in patients requiring short term central venous
catheterization. |