Recruiting NA Dialysis; Complications

New treatment option for Dialysis; Complications

Official title Access Cannulation Trial II

ClinicalTrials.gov ID: NCT05490225

What this study is testing

What it's testing
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.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Inclusion:
  • 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...
  • Arterial/Pull Zone: \_\_\_\_\_ mm deep
  • Venous/Push Zone: \_\_\_\_\_ mm deep OR
See the full eligibility criteria
Who can join
  • Inclusion:
  • 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 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:
  • 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...
  • The subject has either a radio-cephalic, brachio-cephalic or transposed brachio-basilic fistula. Exclusion:
  • 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 #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...
  • 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 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...
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Dothan, Alabama, United States
  • Riverside, California, United States
  • Boston, Massachusetts, United States
  • Hyde Park, New York, United States
  • Orangeburg, South Carolina, United States
  • Austin, Texas, United States
  • Dallas, Texas, United States
  • Roanoke, Virginia, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Dothan, Alabama, United States; Riverside, California, United States; Boston, Massachusetts, United States; Hyde Park, New York, United States; Orangeburg, South Carolina, United States; Austin, Texas, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.