Is NCT05490225 recruiting in Hyde Park, NY?

Yes, NCT05490225 is currently recruiting participants at its Hyde Park, NY location. This dialysis; complications clinical trial is actively enrolling qualified participants.

How do I join the dialysis; complications clinical trial in Hyde Park?

To join this clinical trial in Hyde Park, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Hyde Park clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Dialysis; Complications Clinical Trial in Hyde Park, NY

About This Dialysis; Complications Study in Hyde Park

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.

Sponsor: Voyager Biomedical

Who Can Participate

Inclusion Criteria

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:

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.

Exclusion Criteria

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

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Hyde Park?

Yes, this clinical trial (NCT05490225) has an active research site in Hyde Park, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Dialysis; Complications Treatment Options in Hyde Park, NY

If you're searching for dialysis; complications treatment options in Hyde Park, NY, this clinical trial (NCT05490225) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Hyde Park research site is actively enrolling participants for this clinical trial. You'll receive care from experienced dialysis; complications specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all dialysis; complications clinical trials near you to find additional studies recruiting in your area.

Dialysis; Complications Clinical Trial in Hyde Park, NY

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