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Dialysis; ComplicationsACT IINCT05490225

Access Cannulation Trial II

A study testing VenaSure in people with Dialysis; Complications and Vascular Access Complication, run by Voyager Biomedical at 8 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
VenaSure
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
8 sitesUnited States
Study dates
23 Apr 2025to 25 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • OR
  • 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:
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  • 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.

Who cannot join

  • 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
  • Venous/Push Zone: _____ mm in depth Note: these values should match inclusion criteria #1
  • 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
Show all 29Show fewer
  • 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).
  • The subject is <18 years of age.
  • The subject plans to become pregnant prior to their potential treatment date.
  • The subject has a body mass index >50kg/m2.
  • The subject has a known clinically significant bleeding or coagulation disorder, including but not limited to low platelet count (<50,000), hypercoagulable state (e.g., antithrombin IE deficiency, antiphospholipid or anticardiolipin antibodies, Factor V Leiden, circulating Lupus anticoagulant, current, heparin-induced thrombocytopenia, protein C or S deficiency, history of recurrent deep vein thrombosis not related to AV access).
  • The subject has an active malignancy.
  • The subject has a known or suspected allergy to titanium, aluminum, or vanadium.
  • The subject has had a significant cardiovascular event/intervention that makes them a poor surgical candidate such as myocardial infarction, angioplasty, or stent placement within 3 months of implantation.
  • The subject has had a significant peripheral vascular disease requiring a major intervention within the previous 12 months (in the target limb).
  • The subject has had a significant neurovascular event such as stroke or major intervention within the previous 12 months.
  • The subject has an uncontrolled major symptomatic medical problem per the Investigator.
  • The subject has a likelihood of poor protocol compliance due to mental incapacity, an inability to understand treatment instructions, or for any other reason in the opinion of the Investigator.
  • The subject is currently participating in another investigational drug or device investigation that could clinically interfere with the endpoints of this investigation.
  • The subject's conversion to home hemodialysis is anticipated at any point during their foreseeable participation in this investigation.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Britnee Ochabski contact

9493224050

bochabski@voyagerbiomedical.com

Supraj Amunje contact

samunje@voyagerbiomedical.com

8 sites in 1 country

United States8 sites, 8 recruiting

  • Cardiothoracic and Vascular Surgeons

    Austin, Texas, 78756

    Shir Yelovitch, PhD, 512-459-8753 ext. 214, SYelovitch@ctvstexas.com

    Adam Turley, MD

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Danielle Montano CRC, 617-525-8555, dmontano2@bwh.harvard.edu

    Mohamed Hussain, MD

    Recruiting

  • Baylor Scott & White

    Dallas, Texas, 75246

    Rehma Shabbir, 214-820-1722, Rehma.Shabbir@BSWHealth.org

    Stephen Hohmann, MD

    Recruiting

  • Trinity Research Group

    Dothan, Alabama, 36301

    Emily Ivey Director, 334-456-5511, eivey.trinity@gmail.com

    Jason Beaver, MD

    Recruiting

  • Northwell Health

    Hyde Park, New York, 11042

    Yana Etkin, MD, (516) 233-3701, yetkin@northwell.edu

    Victoria Wairimu, (516) 233-3701, mwairimu@northwell.edu

    Recruiting

  • MUSC Health Orangeburg

    Orangeburg, South Carolina, 29118

    Kristen Covington, (803) 395-2021, covingkr@musc.edu

    Mark London, MD

    Recruiting

  • Apex Research

    Riverside, California, 92505

    Karina Trejo, 951-529-4708, ktrejo@nephrologyamg.com

    Dalia Dawoud, MD

    Recruiting

  • Fairlawn Surgery Center

    Roanoke, Virginia, 24014

    Aleisha Umber Director, 540-904-6170, AUMBER@FSCMED.COM

    Ryan Evans, MD

    Recruiting

Other trials in United States

About this study

Official title: A Study to Evaluate the Safety and Effectiveness of Voyager's Access Device for Patients Undergoing Routine Hemodialysis (Access Cannulation Trial II)

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.

Read the detailed description

This clinical investigation is estimated to last approximately 48-60 months, from initial participant enrollment until all data collection is complete on the final participant. After the patient has the study device implanted, they will be observed for 6 weeks as the implant site heals. The patient will be monitored for 36 months after device implantation as they undergo routine dialysis. Subjects will exit the investigation after the last visit and no device-related adverse events have been identified or are being monitored

Being tested
VenaSure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VenaSureDevice

    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.

Study groups in NCT05490225
Study groupRoleWhat they receive
Ark ImplantationExperimentalSingle 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).
Receives: Device: VenaSure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. 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)

    Measured: 12 months

Secondary outcomes (7)

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

    Cumulative duration (days) of hemodialysis catheter exposure (post device implantation), including CVC reinsertion events

    Measured: 12 months

  2. To further evaluate the safety of the study device

    Incidence and types of device-related complications

    Measured: 12 months

  3. To further evaluate the safety of the study device

    Days to successful cannulation and hemodialysis through the device

    Measured: 12 months

  4. To further evaluate the safety of the study device

    Vascular access interventions required to achieve the primary effectiveness endpoint

    Measured: 6mo from approved cannulation through the device

  5. To further evaluate the safety of the study device

    Time required to achieve the primary endpoint for all evaluable subjects.

    Measured: 36 months

  6. To further evaluate the safety of the study device

    (Post intervention) Functional Cumulative Patency utilizing Kaplan-Meier methodology

    Measured: 3 months, 6 months, 12 months

  7. To further evaluate the safety of the study device

    Initial Safety Assessment (Time Frame = 4 weeks from initial implantation) adjudicated by a Data Monitoring Committee (DMC).

    Measured: 4 weeks from initial implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2022
  2. Study start23 Apr 2025
  3. Primary completion25 Mar 2027 (estimated)
  4. Study completion25 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a pivotal, interventional, prospective, single arm, open-label study.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05490225
Sponsor's protocol ID
Access Cannulation Trial II
Acronym
ACT II
Status last verified
Oct 2025
First submitted
4 Aug 2022
Last updated
29 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: If data is shared after study completion it will be redacted of any PHI

Questions about this trial

What is this clinical trial studying?

A study testing VenaSure in people with Dialysis; Complications and Vascular Access Complication, run by Voyager Biomedical at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Britnee Ochabski (9493224050, bochabski@voyagerbiomedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To demonstrate the effectiveness of the study device in facilitating cannulation of arteriovenous fistulas (AVFs) for hemodialysis. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05490225.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.

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