Is NCT07153939 recruiting in Jacksonville, FL?

Yes, NCT07153939 is currently recruiting participants at its Jacksonville, FL location. This chronic kidney disease clinical trial is actively enrolling qualified participants.

How do I join the chronic kidney disease clinical trial in Jacksonville?

To join this clinical trial in Jacksonville, 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 Jacksonville 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.

Chronic Kidney Disease Clinical Trial in Jacksonville, FL

About This Chronic Kidney Disease Study in Jacksonville

This study will evaluate the Velocity Percutaneous Arteriovenous Fistula (pAVF) System, a new minimally invasive method for creating dialysis access. People with kidney failure often require dialysis, which depends on having a reliable arteriovenous fistula (AVF). Traditionally, AVFs are created with surgery, but surgery can involve incisions, longer recovery, and sometimes additional procedures before the AVF can be used. The Velocity System is designed to create an AVF through a small puncture in the skin using a catheter-based approach, without open surgery. This pivotal study will assess how safe the procedure is and how well it works for patients who need dialysis. The study will take place at multiple centers in the United States and will enroll adults with kidney failure who are candidates for fistula creation. Participants will undergo the Velocity procedure and then be followed closely with exams, ultrasounds, and dialysis assessments for up to five years. Taking part is voluntary. Patients may benefit from a less invasive approach to dialysis access, but the main goal is to collect information that could improve future care for people with kidney failure.

Sponsor: Venova Medical

Who Can Participate

Inclusion Criteria

ESRD requiring hemodialysis access or CKD with anticipated need for hemodialysis within 6 months

Cubital perforating vein diameter ⩾ 2.0 and ⩽ 5.0 mm

Proximal radial artery diameter ⩾ 2.0 and ⩽ 4.0 mm

Age \> 18 years and \< 80 years

Willing and competent to give written informed consent

Willing and able to complete all study assessments and follow-up requirements

Exclusion Criteria

Study extremity systolic blood pressure \< 100mmHg

Subjects with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test

Subjects with a previous ipsilateral arterio-venous graft or previous ipsilateral upper arm AVF.

Distance between Cubital Perforating Vein and Proximal Radial Artery \> 3.0 mm

Cephalic vein diameter \< 2.5 mm at any point from the CPV to the axillary vein

Central venous occlusion ipsilateral of the study extremity

Severe calcification of the radial artery that significantly impairs ultrasound visualization (e.g., acoustic shadowing) and thus precludes safe or accurate device deployment.

Evidence of active systemic infections or localized to the procedure access site within the past 7 days

History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months prior to study entry, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina

Any contraindication to antiplatelet therapy

Currently being treated with another investigational device or drug

Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated

Uncontrolled or poorly controlled diabetes defined as a HbA1C \> 10%

Known hypercoagulable condition, bleeding diathesis or coagulation disorder

Lymphedema of the study extremity

Scheduled kidney transplant within 6 months of enrollment

Peripheral white blood cell count \< 1,500 cells/μL or \> 13,000 cells/μL and neutrophil \> 80%

Platelet count \< 75,000 cells/ μL

Current diagnosis of carcinoma (unless in remission \> 1 year)

Pregnant or currently breast feeding

Allergies to nickel or nickel titanium alloy (NiTi) or any of the components of the Velocity Implant or Delivery System

Any other medical condition that in the opinion of the investigator would put the welfare of the subject at risk or confound interpretation of the study data

Investigator determines that vascular anatomy at intended index procedure site is inappropriate for use of investigational device prior to attempting needle access.

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 Jacksonville?

Yes, this clinical trial (NCT07153939) has an active research site in Jacksonville, FL 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.

Chronic Kidney Disease Treatment Options in Jacksonville, FL

If you're searching for chronic kidney disease treatment options in Jacksonville, FL, this clinical trial (NCT07153939) 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 Jacksonville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced chronic kidney disease 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 chronic kidney disease clinical trials near you to find additional studies recruiting in your area.

Chronic Kidney Disease Clinical Trial in Jacksonville, FL

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