A prospective, open-label, Single-center, single-arm, interventional clinical investigation to evaluate the safety and performance of the NewTech Short-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 Short-Term Hemodialysis Catheter by assessing procedural success, defined as successful catheter insertion with immediate adequate flow suitable for hemodialysis, hemoperfusion, or apheresis therapy
研究概览
简要总结
This is a prospective, interventional, open-label, single-arm clinical study designed to evaluate the performance, safety, and usability of the NewTech Short-Term Hemodialysis Catheter in real-world clinical settings for patients requiring temporary vascular access for hemodialysis, hemoperfusion, or apheresis therapy.
A total of 90 adult subjects (aged above 18 years) will be enrolled across single hospital site. Each subject will undergo catheter insertion via a central vein (e.g., internal jugular or femoral) on Day 1, followed by structured assessments throughout the catheter use period and post-removal until Day 30 from insertion. The expected in-use duration of the catheter ranges from 5 to 14 days, depending on the patient’s clinical condition.
The study includes defined evaluation time points on Day 7 , and Day 30 to assess device performance, clinical site outcomes, and any adverse events. Subjects will continue to be monitored even after catheter removal to capture potential delayed complications such as infection, thrombosis, or device-related irritation.
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.Subjects aged above 18 years requiring short-term vascular access for hemodialysis, hemoperfusion, or apheresis therapy.
- •2.Subjects for whom percutaneous central venous catheterization is clinically indicated and feasible.
- •3.Subjects who provide written informed consent prior to participation in the study.
- •4.Subjects who are clinically stable to undergo elective catheter insertion.
- •5.Subjects with accessible central venous anatomy for safe catheter placement eg internal jugular or subclavian vein).
- •6.Willing and able to comply with all study procedures and follow-up requirements.
排除标准
- •1.Presence or suspicion of device-related infection, bacteremia, or septicemia.
- •2.History of severe chronic obstructive pulmonary disease that may complicate venous access.
- •3.Prior irradiation at the intended catheter insertion site.
- •4.Previous venous thrombosis or vascular surgical intervention at the intended insertion site.
- •4.Local tissue conditions preventing proper device stabilization and or tunneling.
- •5.Known allergy or hypersensitivity to polyurethane, heparin, or any materials used in the device.
- •6.Participation in another clinical study that may interfere with the current study outcomes.
- •7.Any medical or psychiatric condition that, in the investigator’s opinion, may render the subject unsuitable for the study or interfere with compliance.
结局指标
主要结局
1.To evaluate the clinical safety and performance of the NewTech Short-Term Hemodialysis Catheter by assessing procedural success, defined as successful catheter insertion with immediate adequate flow suitable for hemodialysis, hemoperfusion, or apheresis therapy
时间窗: Screening Day & Procedure day, Post procedure Day2, Follow up Day7, Follow up Day30
次要结局
- 1.To assess the usability and handling characteristics of the catheter as reported by healthcare professionals, including ease of insertion, catheter positioning, and overall operability.(2.To evaluate the functional performance of the catheter during routine clinical use, such as adequacy of flow and reliability of connections.)
研究者
Dr Nitin tulsyan
Heart and General Hospital Jaipur