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.
Subject is an adult patient ≥ 18 years of age.
Subject with the ability to attend "in-center" hemodialysis.
Subject has a requirement of hemodialysis 3 times/week.
Subject has an AVF that was determined to be mature by standard clinical definition
Subject has an existing arteriovenous graft.
Subject has any active infection within the past 90 days.
Subject is currently receiving or planning home hemodialysis.
Subject has a distorted anatomy and/or local vascular injury.
Single group
OnePoint Dialysis Cannula
DeviceSingle-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.
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.
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This trial is not recruiting at the moment. You can still explore other options:
