A prospective, open-label, Single-center, single-arm, interventional clinical investigation to evaluate the safety and performance of the NewTech Long-Term Hemodialysis Catheter for vascular access in patients undergoing hemodialysis, hemoperfusion, or apheresis therapy in real-world clinical settings.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1.To evaluate the clinical safety and performance of the NewTech Long-Term Hemodialysis Catheter by assessing successful catheter placement and sustained functional use, defined as the ability to deliver adequate blood flow for hemodialysis, hemoperfusion, or apheresis therapy over the intended duration of use without device-related failure.
研究概览
简要总结
This is a prospective, open-label, single-center, single-arm, interventional clinical investigation designed to evaluate the safety and performance of the NewTech Long-Term Hemodialysis Catheter for vascular access in patients undergoing hemodialysis, hemoperfusion, or apheresis therapy in real-world clinical settings.
A total of 90 adult subjects (aged above 18 years) will be enrolled across single hospital or dialysis center. Each subject will receive the NewTech Long-Term Hemodialysis Catheter via percutaneous insertion into a central vein (typically internal jugular) under sterile conditions on Day 1. The catheter is intended for extended use and will remain in place for a variable duration depending on clinical need. Each subject will be followed for 60 days from the date of insertion, regardless of whether the catheter is removed earlier.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults aged 18 years and above requiring long-term vascular access 30 days or more for maintenance hemodialysis.
- •2.Patients for whom tunneled central venous catheterization is clinically indicated and feasible.
- •3.Subjects who are clinically stable and medically cleared to undergo catheter implantation under sterile surgical or interventional conditions.
- •4.Patients with adequate central venous anatomy eg internal jugular vein or subclavian vein confirmed via imaging or physician assessment.
- •5.Subjects who provide written informed consent prior to participation.
- •6.Willing and able to adhere to all study procedures, scheduled follow-up, and maintenance protocols.
排除标准
- •1.Presence of local or systemic infection, bacteremia, or septicemia at the time of planned catheterization.
- •2.History of central vein stenosis or thrombosis at the proposed catheterization site.
- •3.Prior radiation therapy or surgical modification at the intended catheter insertion site.
- •5.Severe coagulopathy or bleeding disorders not corrected before the procedure.
- •6.Skin conditions or anatomical abnormalities that may impair catheter tunneling or exit site healing.
- •7.Life expectancy less than 3 months or underlying terminal illness not related to End-Stage Renal Disease ESRD.
- •8.Participation in another investigational study that may interfere with the current investigation.
- •9.Any medical or psychiatric condition that, in the opinion of the investigator, could interfere with protocol compliance or place the patient at undue risk.
结局指标
主要结局
1.To evaluate the clinical safety and performance of the NewTech Long-Term Hemodialysis Catheter by assessing successful catheter placement and sustained functional use, defined as the ability to deliver adequate blood flow for hemodialysis, hemoperfusion, or apheresis therapy over the intended duration of use without device-related failure.
时间窗: Screening day & Procedure day, Post Procedure Day2, Follow up Day7, Follow up Day30, Follow up Day60
次要结局
- 1.To assess the usability and handling characteristics of the catheter as reported by healthcare professionals, including ease of insertion, subcutaneous tunneling, fixation stability, and maintenance.(2.To evaluate the long-term functional performance, including flow consistency, catheter patency, and duration of successful use without intervention.)
研究者
Dr Nitin tulsyan
Heart and General Hospital Jaipur