This is an early feasibility, pre-market, prospective, interventional, single-arm, non-randomized / open-label study intended to support a future pivotal IDE study for eventual FDA clearance of the study device based on the safety and efficacy of the device in cannulating arteriovenous fistulas (AVFs) for hemodialysis procedures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Single-site vascular access device intended to be used in patients receiving hemodialysis
Dialysis Cannulation Data CRF
Percentage of attempted device cannulations that successfully result in completion of the prescribed hemodialysis treatment sessions over a 30-day period.
Time frame: 30 days
Dialysis Cannulation Data CRF
Proportion of subjects that, using the device, successfully complete their prescribed number of dialysis treatments over a 30-day period, excluding treatments that fail for other reasons.
Time frame: 30 days
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