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 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1. Patient aged Ã¢â?°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

•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

发起方

Global Medikit Ltd