Health Condition 1: I770- Arteriovenous fistula, acquired
Conditions
Interventions
Intervention1: NewTech Short-Term Hemodialysis Catheter: The Dialysis Catheter is a chronic, multi-lumen, radiopaque, polyurethane catheter with a polyester cuff and two female Luer locking adapters.
Sponsors
Newtech Medical Devices Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 therapyTimepoint: Screening Day & Procedure day, Post procedure Day2, Follow up Day7, Follow up Day30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 3.To monitor the incidence and type of adverse events or complications, including but not limited to infections, thrombosis, dislodgement, and device malfunction. 4.To collect qualitative and quantitative feedback from users regarding catheter management, patient safety, and ease of care. 5.To identify and document any device-related issues or operational concerns encountered throughout the study period. Timepoint: Screening Day & Procedure day, Post procedure Day2, Follow up Day7, Follow up Day30 | — |
Countries
India
Contacts
Public ContactMr Praveen Shukla
Newtech Medical Devices PVT LTD
Outcome results
None listed