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Clinical Trials/CTRI/2021/09/036597
CTRI/2021/09/036597
Not yet recruiting
未知

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

Global Medikit Ltd0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: Z452- Encounter for adjustment and management of vascular access device

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: Z452- Encounter for adjustment and management of vascular access device
Sponsor
Global Medikit Ltd
Status
Not yet recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Pms

Investigators

Sponsor
Global Medikit Ltd

Eligibility Criteria

Inclusion Criteria

  • •1\. Patient aged ââ?°Â¥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

  • •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

Outcomes

Primary Outcomes

Not specified

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