N/A
N=15
Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis
End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT05493423 ↗Enrolled (actual)
15
Serious AEs
3.3%
Results posted
Feb 2025
Primary outcome: Primary: Percentage of Successful Hemodialysis Sessions — 100; 98.9 percentage of successful sessions — p=.008
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- V Needle AV Fistula Set (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Hemotek Medical Inc
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Successful Hemodialysis Sessions |
100; 98.9 | .008 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05493423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.