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 groupLocations
8Alabama
Trinity Research Group36301, Dothan United States
California
Apex Research92505, Riverside United States
Massachusetts
Brigham and Women's Hospital02115, Boston United States
New York
Northwell Health11042, Hyde Park United States
Sponsors and collaborators
Voyager Biomedical
Lead sponsor
Source ClinicalTrials.gov