Health Condition 1: I770- Arteriovenous fistula, acquired
Conditions
Interventions
Intervention1: NewTech Long-Term Hemodialysis Catheter: The Dialysis Catheter is a chronic, multi-lumen, radiopaque, polyurethane catheter with a polyester cuff and two female Luer locking adapters. T
Sponsors
Newtech Medical Devices Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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. 4.Known hypersensitivity to materials used in the catheter eg polyurethane, antimicrobial coatings, heparin. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Screening day & Procedure day, Post Procedure Day2, Follow up Day7, Follow up Day30, Follow up Day60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 3.To monitor and document the incidence, type, and timing of adverse events or complications, such as CRBSIs, thrombosis, dislodgement, malfunction, or need for replacement. 4.To collect qualitative feedback from clinicians on the overall user experience during long-term care and management. 5.To identify and evaluate any device malfunctions or operational issues, including catheter damage, Luer lock integrity, or difficulty during handling or removal. Timepoint: Screening day & Procedure day, Post Procedure Day2, Follow up Day7, Follow up Day30, Follow up Day60 | — |
Countries
India
Contacts
Public ContactMr Praveen Shukla
Newtech Medical Devices PVT LTD
Outcome results
None listed