Study to evaluate safety and performance of Acent Central Venous Catheter in patients requiring central venous catheterization.

Not yet recruiting

• Conditions: Encounter for adjustment and management of vascular access device,

• Registration Number: CTRI/2021/09/036597
• Lead Sponsor: Global Medikit Ltd

Brief Summary

A prospective, open label, multi-centre, single arm, observational,post marketing clinical follow-up study to evaluate safety and performance ofAcent Central Venous Catheter in patients requiring central venouscatheterization during routine clinical practice.

**Primary objective:** The primary objective of this study is to evaluate thecomplications associated (safety) with Acent CVC (Seldinger technique) duringand post catheterization in patients requiring short term central venouscatheterization.

**Secondary objective:** The secondary objective is to evaluate performance ofAcent CVC (Seldinger technique) in patients requiring short term central venouscatheterization.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-20
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (3)

BAJ RR Hospital; 🇮🇳 Thane, MAHARASHTRA, India

Jivanrekha Multispecialty Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Shree Ashirwad Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

BAJ RR Hospital

🇮🇳Thane, MAHARASHTRA, India

Dr Ashpak Bangi

Principal investigator

9820576741

nandadrpreeti@gmail.com