Access Cannulation Trial II
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVoyager Biomedical
About this trial
This is a pivotal, interventional, prospective, single-arm, open-label, multi-site clinical investigation intended to support FDA clearance of the study device based on the safety and efficacy of the device in cannulating arteriovenous fistulas (AVFs) for hemodialysis procedures.
Eligibility criteria
Qualifiers
Arterial/Pull Zone: _____ mm deep
Venous/Push Zone: _____ mm deep
Failed access attempt in a fistula that was previously approved for cannulation, or
Unable to palpate the fistula such that cannulation is not possible without patient risk.
Disqualifiers
None
Trial design
Treatments tested in this trial
- VenaSure
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov