Access Cannulation Trial II

NCT05490225 | Recruiting DMC FDA Device

• 1 other identifier: Access Cannulation Trial II
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Dialysis; Complications; Vascular Access Complication

Outcome Measures

Primary Outcomes (2)

• To demonstrate the effectiveness of the study device in facilitating cannulation of arteriovenous fistulas (AVFs) for hemodialysis.

  Incidence of success for achieving clinically functional access within a 6-month timeframe from approved cannulation through the study device.

  6 months

• To evaluate the safety of the study device.

  The assessment and occurrence of device-related, serious adverse events (SAEs) of clinical interest (infection, aneurysm, complicated seroma) during a 12- month follow-up period from initial implantation adjudicated by a Data Monitoring Committee (DMC)

  12 months

Secondary Outcomes (7)

• To investigate time-related parameters surrounding the study device in facilitating hemodialysis.

  12 months

• To further evaluate the safety of the study device

  12 months

• To further evaluate the safety of the study device

  12 months

• To further evaluate the safety of the study device

  6mo from approved cannulation through the device

• To further evaluate the safety of the study device

  36 months

Other Outcomes (3)

• Exploratory Outcome 1

  36 months

• Exploratory Outcome 2

  SCRN/BSLN, 6 months, 12 months

• Exploratory Outcome 3

  12 months

Study Arms (1)

Ark Implantation

EXPERIMENTAL

Single arm study. Depending on the clinical needs of the patient, the physician will decide if a single return device is needed (ex. easily cannulatable arterial pull site but the venous return access site is poorly accessible for cannulation) or two devices (both arterial pull and venous return are poorly accessible for cannulation).

Device: VenaSure

Interventions

VenaSure DEVICE

The device will be surgically implanted at the access site in subjects undergoing routine hemodialysis. The device is expected to provide a target to aid in long-term cannulation success.

Ark Implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject's AVF is deemed uncannulatable because:
• The subject's anticipated cannulation zone(s) is/are \>6mm in depth from the surface of the skin to the anterior wall of the access vein as confirmed by ultrasound within 8 weeks prior to device implantation (each zone, Arterial/Pull and Venous/Push, shall be assessed independently of one another for device placement):
• Arterial/Pull Zone: \_\_\_\_\_ mm deep
• Venous/Push Zone: \_\_\_\_\_ mm deep
• The subject's dialysis unit (which includes an experienced cannulator) attests that repeated cannulation is not achievable in their clinic due to one of the following:
• 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.
• The access surgeon caring for the subject attests that the device is likely to be at least equivalent to other methods (such as venous transposition or suction-assisted lipectomy) that could make the AVF easier to access and reduce risk of cannulation infiltrations.
• The subject has either a radio-cephalic, brachio-cephalic or transposed brachio-basilic fistula.

You may not qualify if:

• The subject's access vein is \>15mm in depth at either cannulation zones as measured by ultrasound within 8 weeks prior to device implantation.
• Arterial/Pull Zone: \_\_\_\_\_ mm in depth
• Both bidimensional measurements in the subject's access vein have a diameter of \<4mm, taken with a tourniquet in place or through manual compression to the outflow, as measured by ultrasound within 8 weeks prior to device implantation (cannulation zone specific - one zone does not affect the other's eligibility).
• Arterial/Pull Zone: \_\_\_\_\_ x \_\_\_\_\_ mm in diameter
• Venous/Push Zone: \_\_\_\_\_ x \_\_\_\_\_ mm in diameter
• The subject has a flow rate of \<550mL/min in the inflow artery proximal to the arterial anastomosis as measured by ultrasound within 8 weeks prior to device implantation.
• Flow: \_\_\_\_\_ mL/min
• The subject does NOT have a prescription to receive maintenance hemodialysis at least 2 times per week.
• The subject's life expectancy is \<1 year per the Investigator.
• The subject does NOT have a signed and dated consent form.
• The AVF is a non-transposed basilic or brachial vein outflow AVF.
• The subject has high flow rates placing them at risk for heart failure and death at the discretion of the Investigator.
• The subject has a known skin infection, hypersensitive skin, skin breakdown/erosion or skin allergies at the potential implant sites.
• The subject has a known active systemic infection or positive blood cultures present.
• The subject's AVF has undergone a major revision and at the discretion of the Investigator can impact fistula viability and device placement (such as DRIL or PTFE segment insertion, banding, aneurysm repair, etc.), or the subject has had an occurrence of and/or intervention for AV access stenosis or thrombosis within the past month (excluded to avoid unnecessary placement into an AVF with a high likelihood of failure).

Sponsors & Collaborators

• Voyager Biomedical: lead

Study Sites (8)

Trinity Research Group

Dothan, Alabama, 36301, United States

RECRUITING

Apex Research

Riverside, California, 92505, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Northwell Health

Hyde Park, New York, 11042, United States

RECRUITING

MUSC Health Orangeburg

Orangeburg, South Carolina, 29118, United States

RECRUITING

Cardiothoracic and Vascular Surgeons

Austin, Texas, 78756, United States

RECRUITING

Baylor Scott & White

Dallas, Texas, 75246, United States

RECRUITING

Fairlawn Surgery Center

Roanoke, Virginia, 24014, United States

RECRUITING

Related Links

• Related Info

Study Officials

• Stephen Hohmann, MD

  Baylor Scott and White Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Britnee Ochabski

CONTACT

9493224050; bochabski@voyagerbiomedical.com

Supraj Amunje

CONTACT

samunje@voyagerbiomedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a pivotal, interventional, prospective, single arm, open-label study.

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 5, 2022
• Study Start: April 23, 2025
• Primary Completion (Estimated): March 25, 2027
• Study Completion (Estimated): March 25, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)