Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis
Completed · Not applicable
Conditions studied: End Stage Renal Disease
In brief
This study is a prospective, multi-center, single-arm study with subjects acting as their own control designed to confirm the safety, performance, and usability of the V Needle, a new safety needle for use during in-clinic hemodialysis that is designed to automatically generate a partial occlusion of the internal fluid path and trigger the hemodialysis machine to alarm and shut off if a complete dislodgement of the venous needle from the arm inadvertently occurs.
Key facts
- Study ID
- NCT05493423
- Run by
- Hemotek Medical Inc
- People needed
- 15
- Starts
- 2022-11-07
- Expected to finish
- 2023-07-17
- Last updated by the study team
- 2025-02-05
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects with end-stage renal disease receiving chronic hemodialysis in a clinical setting.
- Subjects must be able to receive hemodialysis with the Hemotek 15-gauge, 1 inch length V Needle, with 12 inch tubing.
- Age greater than or equal to 22 years old at screening.
- Vascular access via a mature arteriovenous (AV) fistula or graft in the arm and determined to be adequate for a chronic hemodialysis therapy.
- AV fistula has already been demonstrated to adequately permit one or more hemodialysis sessions.
- Subject prescribed blood flow rates between 200 ml/min and 450 ml/min
- In women with child-bearing potential, negative urine or serum pregnancy test at Screening.
- Subject able to communicate effectively with investigative staff, competent and willing to give written informed consent, and able to comply with entire study procedures.
- Hemoglobin ≥9 g/dL (consistent with KDOQI guidelines)
- Normal platelet count (≥150,000 /mm3)
- International Normalized Ratio (INR) ≤ 1.5
You may not qualify if…
- Subjects receiving chronic hemodialysis with a vascular catheter.
- Subjects with vascular access that is determined by the clinician to be unacceptable for a hemodialysis procedure.
- Patients with a bleeding diathesis
- Patients receiving anti-coagulants
- Previous vascular access surgery (≤30 days from study entry) or planned access surgery
- Known hypersensitivity to any imaging agents (e.g., contrast) that may be required during the study period
- Patients with confirmed vasculitis
- Vascular access infection or systemic active infection within 30 days of study entry
- Life expectancy less than 12 months
- Planned renal transplantation or planned conversion to peritoneal dialysis
- Subjects with any condition determined by the investigator that precludes them from safely participating in the study.
Where it is running
- Davita — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.