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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 试验地点
- 3
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient aged ≥18 at the time of enrolment
- •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
- •Patient or his/her legally authorized representative (if applicable) agrees to provide written informed consent
- •Patient is willing to comply with clinical investigation plan (CIP) specified follow-up evaluations.
排除标准
- •Patient with contraindications for catheterization with CVC mentioned in the IFU of study device
- •Patient with a history of thrombocytopenia
- •Patient with a history of bleeding disorders
- •infection signs, wounds and subcutaneous haematoma close to the puncture site
- •Currently participating in another clinical study with experimental drugs or devices
- •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.
结局指标
主要结局
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.
时间窗: time points would be at the day of surgery and on the day of catheter removal (As per SOC)
次要结局
- 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)