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

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. - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/09/036597
Enrollment
88
Registered
2021-09-17
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z452- Encounter for adjustment and management of vascular access device

Interventions

Intervention1: Acent-1, 2 & 3 ââ?¬â?? Central venous catheter (CVC) (Single, Double & Triple Lumen, Seldinger technique): Dose: NA, Frequency: NA, Route of administration: As per standard of care, Du

Sponsors

Global Medikit Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.Timepoint: time points would be at the day of surgery and on the day of catheter removal (As per SOC)—

Secondary

MeasureTime frame
The secondary objective is to evaluate performance of Acent CVC (Seldinger technique) in patients requiring short term central venous catheterization.Timepoint: At the day of surgery—

Countries

India

Contacts

Public ContactDr Jatin Soni

Eupraxia Centre For Clinical Excellence LLP

jsoni@eupraxiaconsulting.com9630635333

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026