Ark Device for Vascular Access Complications
(ACT II Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is the Ark Device for Vascular Access Complications safe for humans?
How is the Ark Device treatment different from other treatments for vascular access complications?
The Ark Device is unique because it is designed to improve the reliability of accessing arteriovenous fistulas, which are crucial for hemodialysis, by overcoming technical barriers to using blunt needles. This approach is different from other treatments that may not specifically address the challenges of reliable needle access in mature fistulas.678910
What is the purpose of 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.
Research Team
Stephen Hohmann, MD
Principal Investigator
Baylor Scott and White Health
Eligibility Criteria
This trial is for individuals with difficult-to-access arteriovenous fistulas (AVFs) used for hemodialysis. Candidates must have had multiple failed access attempts, AVFs that are not palpable or too tortuous, and certain measurements of the fistula as determined by ultrasound.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Implantation and Healing
The study device is implanted and participants are observed for 6 weeks as the implant site heals
Initial Safety Assessment
Initial safety assessment of the study device is conducted
Treatment and Monitoring
Participants are monitored for 36 months after device implantation as they undergo routine dialysis
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ark Device
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioTex, Inc.
Lead Sponsor
Voyager Biomedical
Lead Sponsor