Actively Recruiting
A Study to Evaluate the Safety and Effectiveness of Voyager's Access Device for Patients Undergoing Routine Hemodialysis (Access Cannulation Trial II)
Led by Voyager Biomedical · Updated on 2025-10-29
100
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the safety and effectiveness of Voyager Biomedical's Access Device designed to help patients undergoing routine hemodialysis by facilitating the cannulation of arteriovenous fistulas (AVFs). This pivotal, interventional, single-arm, open-label study aims to support FDA clearance of the device by assessing its ability to improve access during dialysis and ensure patient safety. The study addresses challenges where AVFs are difficult to cannulate due to depth or accessibility issues and evaluates the device as a potential alternative to other surgical methods. Participants will have the VenaSure device surgically implanted at the dialysis access site, tailored to their clinical needs. Depending on vascular access conditions, one or two devices may be implanted to assist arterial and/or venous cannulation. After implantation, patients will be observed for 6 weeks to allow healing. Following this, they will be monitored for 36 months while undergoing routine hemodialysis to assess the device's long-term performance and safety. During the study, participants will have regular follow-up visits to monitor healing, device function, and any adverse effects. Researchers will collect data on the device's ability to facilitate cannulation at 6 months and evaluate safety outcomes at 12 months and beyond. The study lasts approximately 48 to 60 months from enrollment until data collection is complete. Patients exit the study after the final visit with no ongoing device-related safety concerns.
CONDITIONS
Brief Title
Access Cannulation Trial II
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Have an arteriovenous fistula (radio-cephalic, brachio-cephalic, or transposed brachio-basilic) deemed difficult to cannulate due to depth greater than 6mm or failed cannulation attempts
- Dialysis unit confirms repeated cannulation is not achievable or fistula is not palpable without risk
- Access surgeon agrees device is likely at least equivalent to other surgical methods for improving fistula access
- Prescribed maintenance hemodialysis at least twice per week
- Signed and dated informed consent form
You will not qualify if you...
- Access vein depth greater than 15mm at either cannulation zone
- Access vein diameter less than 4mm in both zones as measured by ultrasound
- Inflow artery flow rate less than 550mL/min proximal to anastomosis
- Life expectancy less than 1 year
- Non-transposed basilic or brachial vein outflow fistula
- Plans to become pregnant before treatment
- Body mass index over 50kg/m2
- Known bleeding or coagulation disorders
- Active malignancy
- Allergy to titanium, aluminum, or vanadium
- Recent major cardiovascular event or intervention within 3 months
- Recent major peripheral vascular or neurovascular intervention within past 12 months
- Known skin infection, hypersensitivity, skin breakdown, or allergies at implant sites
- Active systemic infection or positive blood cultures
- Major AVF revision or recent intervention for stenosis or thrombosis within past month
- Mental incapacity or inability to comply with protocol
- Participation in another investigational drug or device trial affecting endpoints
- Anticipated conversion to home hemodialysis during study period
- Under 18 years of age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants have the VenaSure device surgically implanted at the access site to aid in long-term cannulation success during routine hemodialysis.
1 visit (in-person)
Duration - 6 weeks
Participants are observed for 6 weeks as the implant site heals after device implantation.
Weekly visits for up to 6 weeks
Duration - 36 months
Participants are monitored for 36 months while undergoing routine hemodialysis to evaluate the safety and effectiveness of the implanted device.
Regular visits according to dialysis schedule
Trial Site Locations
Total: 8 locations
1
Trinity Research Group
Dothan, Alabama, United States, 36301
Actively Recruiting
2
Apex Research
Riverside, California, United States, 92505
Actively Recruiting
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
Northwell Health
Hyde Park, New York, United States, 11042
Actively Recruiting
5
MUSC Health Orangeburg
Orangeburg, South Carolina, United States, 29118
Actively Recruiting
6
Cardiothoracic and Vascular Surgeons
Austin, Texas, United States, 78756
Actively Recruiting
7
Baylor Scott & White
Dallas, Texas, United States, 75246
Actively Recruiting
8
Fairlawn Surgery Center
Roanoke, Virginia, United States, 24014
Actively Recruiting
Research Team
B
Britnee Ochabski
S
Supraj Amunje
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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