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New Needle-Sized device could replace surgery for dialysis access

NCT ID NCT07153939

Disease control Sponsor: Venova Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 4 times

Summary

This study tests a new device that creates a connection between an artery and a vein using a small needle puncture instead of open surgery. The goal is to provide a reliable access point for dialysis in people with kidney failure. About 126 adults will be enrolled and followed for up to five years to see if the device is safe and works well.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 126 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. ESRD requiring hemodialysis access or CKD with anticipated need for hemodialysis within 6 months 2. Cubital perforating vein diameter ⩾ 2.0 and ⩽ 5.0 mm 3. Proximal radial artery diameter ⩾ 2.0 and ⩽ 4.0 mm 4. Age \> 18 years and \< 80 years 5. Willing and competent to give written informed consent 6. Willing and able to complete all study assessments and follow-up requirements Exclusion Criteria: 1. Study extremity systolic blood pressure \< 100mmHg 2. Subjects with occlusion of the ulnar or radial artery at any level or an abnormal Allen's test 3. Subjects with a previous ipsilateral arterio-venous graft or previous ipsilateral upper arm AVF. 4. Distance between Cubital Perforating Vein and Proximal Radial Artery \> 3.0 mm 5. Cephalic vein diameter \< 2.5 mm at any point from the CPV to the axillary vein 6. Central venous occlusion ipsilateral of the study extremity 7. Severe calcification of the radial artery that significantly impairs ultrasound visualization (e.g., acoustic shadowing) and thus precludes safe or accurate device deployment. 8. Evidence of active systemic infections or localized to the procedure access site within the past 7 days 9. 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 10. Any contraindication to antiplatelet therapy 11. Currently being treated with another investigational device or drug 12. Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated 13. Uncontrolled or poorly controlled diabetes defined as a HbA1C \> 10% 14. Known hypercoagulable condition, bleeding diathesis or coagulation disorder 15. Lymphedema of the study extremity 16. Scheduled kidney transplant within 6 months of enrollment 17. Peripheral white blood cell count \< 1,500 cells/μL or \> 13,000 cells/μL and neutrophil \> 80% 18. Platelet count \< 75,000 cells/ μL 19. Current diagnosis of carcinoma (unless in remission \> 1 year) 20. Pregnant or currently breast feeding 21. Allergies to nickel or nickel titanium alloy (NiTi) or any of the components of the Velocity Implant or Delivery System 22. 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 23. Investigator determines that vascular anatomy at intended index procedure site is inappropriate for use of investigational device prior to attempting needle access.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome congenital arteriovenous fistula end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arteriovenous fistula Chronic kidney disease End stage renal disease (ESRD) Hemodialysis access

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced Dallas Hospital

    RECRUITING

    Dallas, Texas, 75231, United States

  • Apex Research

    RECRUITING

    Riverside, California, 92505, United States

  • Aqua Research

    RECRUITING

    Houston, Texas, 77058, United States

  • Azura Vascular Care Jacksonville

    RECRUITING

    Jacksonville, Florida, 32218, United States

  • Fresenius Vascular Care San Antonio

    RECRUITING

    San Antonio, Texas, 78207, United States

  • Humble Vascular Surgical Center

    RECRUITING

    Humble, Texas, 77338, United States

  • MUSC Health Orangeburg- Dialysis Access Institute

    RECRUITING

    Orangeburg, South Carolina, 29118, United States

  • San Antonio Surgical Center

    RECRUITING

    San Antonio, Texas, 78216, United States

  • Staten Island University Hospital Northwell Health

    RECRUITING

    Staten Island, New York, 10305, United States

  • Surgical Specialists of Charlotte

    RECRUITING

    Charlotte, North Carolina, 28207, United States

  • Trinity Research Group

    RECRUITING

    Dothan, Alabama, 36301, United States

    Contact Email: •••••@•••••

  • Vascular and Embolization Specialists

    RECRUITING

    Cocoa, Florida, 32926, United States

  • West Coast Kidney Institute Concord

    RECRUITING

    Concord, California, 94520, United States

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