Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05490225

Access Cannulation Trial II

Led by Voyager Biomedical · Updated on 2025-10-29

100

Participants Needed

8

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Access Cannulation Trial II

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • The subject's arteriovenous fistula (AVF) is difficult to cannulate due to depth greater than 6mm as confirmed by ultrasound within 8 weeks prior to device implantation, or repeated cannulation is not possible as confirmed by an experienced cannulator.
  • The access surgeon believes the device is at least as effective as other methods to improve fistula access and reduce cannulation risks.
  • The subject has either a radio-cephalic, brachio-cephalic, or transposed brachio-basilic fistula.
  • The subject is 18 years of age or older.
Not Eligible

You will not qualify if you...

  • The access vein is deeper than 15mm at either cannulation zone by ultrasound within 8 weeks before device implantation.
  • The access vein diameter is less than 4mm in both bidimensional measurements at the cannulation zones.
  • The inflow artery flow rate is less than 550mL/min as measured by ultrasound within 8 weeks prior to device implantation.
  • The subject does not have a prescription for maintenance hemodialysis at least twice weekly.
  • The subject's life expectancy is less than 1 year.
  • The subject has not signed and dated the informed consent form.
  • The AVF is a non-transposed basilic or brachial vein outflow fistula.
  • The subject has high flow rates risking heart failure or death.
  • The subject has known skin infections, hypersensitive skin, skin breakdown, erosion, or allergies at potential implant sites.
  • The subject has an active systemic infection or positive blood cultures.
  • The AVF has had a major revision or recent intervention for stenosis or thrombosis within the past month.
  • The subject is under 18 years old.
  • The subject plans to become pregnant before treatment.
  • The subject's body mass index exceeds 50 kg/m2.
  • The subject has significant bleeding or coagulation disorders.
  • The subject has an active malignancy.
  • The subject is allergic to titanium, aluminum, or vanadium.
  • The subject has had major cardiovascular events or interventions within 3 months.
  • The subject has had significant peripheral vascular disease interventions within 12 months.
  • The subject has had neurovascular events within 12 months.
  • The subject has uncontrolled major symptomatic medical problems.
  • The subject is unlikely to comply with the protocol due to mental incapacity or inability to understand instructions.
  • The subject is participating in another investigational drug or device study interfering with this trial.
  • The subject plans to switch to home hemodialysis during the study period.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

B

Britnee Ochabski

CONTACT

S

Supraj Amunje

CONTACT

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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