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New device aims to simplify dialysis access for kidney patients

NCT ID NCT04634916

Disease control Sponsor: C. R. Bard 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study is testing a device called the WavelinQ EndoAVF System that creates a connection between an artery and a vein (AV fistula) in people who need dialysis. The goal is to make it easier to start and continue dialysis with fewer complications. About 280 adults with end-stage kidney disease will be enrolled to see how well the device works and how safe it is.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BD® WavelinQ™ EndoAVF System (a device to create an arteriovenous fistula)
What this could lead to
If successful, this device could make dialysis access easier and more reliable for people with kidney failure.
What could go wrong
This is a post-market study, so the device is already approved. However, results may vary, and risks include device- or procedure-related serious side effects.

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 220 people

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

Started

Mar 2021

Expected to finish

Sep 2027

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 years and older

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. Subject must be either male or non-pregnant female ≥ 18 years of age with an expected lifespan sufficient to allow for completion of all study procedures. 2. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures. 3. Subject must be willing to comply with the protocol requirements, including clinical follow-up. 4. Subjects who have established, non-reversible kidney failure, who are currently on dialysis at screening or are in immediate need (within 6 months of endoAVF creation) of dialysis. 5. Target treatment vein diameter(s) for endoAVF creation ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Venography. 6. Target treatment artery diameter ≥ 2.0 mm as measured via Duplex Ultrasound (DUS) or Arteriogram. 7. Subject has adequate collateral circulation to the hand, in the opinion of the Investigator. 8. At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the target creation site via a proximal forearm perforating vein. Exclusion Criteria: 1. The subject is in a hypercoagulable state. 2. The subject has known bleeding diathesis. 3. The subject has insufficient cardiac output to support a native fistula in the opinion of the Investigator. 4. Known history of active intravenous drug abuse. 5. "Planned" major surgical procedure within 6 months following index procedure or major surgery within 30 days prior to index procedure. 6. The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated. 7. The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated. 8. Evidence of active infection on the day of the index procedure (temperature of ≥ 38.0° Celsius and/ or WBC of ≥ 12,000 cells/ μL, if collected). 9. The subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up. 10. The subject is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies. 11. The subject has central venous stenosis or central vein narrowing \> 50% based on imaging on the same side as the planned endoAVF creation. 12. Absence of a proximal forearm perforating vein feeding the target cannulation vein(s) from the target creation site via Duplex Ultrasound (DUS) or Venography. 13. Occlusion or stenosis \> 50% of target cannulation vein(s) such as cephalic, median cubital, basilic, etc. assessed via Duplex Ultrasound (DUS) or Venography. 14. Significantly compromised venous or arterial flow in the treatment arm as determined by Investigator and Duplex Ultrasound (DUS) or Venography. 15. Presence of significant calcification at the target endoAVF location that could potentially impact the effectiveness of endoAVF creation as determined by the Investigator.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease 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 End-stage renal disease Kidney disease, end-stage

How to take part

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

  1. The places running it

    15 sites in 2 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Albany Medical Center

    RECRUITING

    Albany, New York, 12208, United States

  • Bluff City Vascular

    RECRUITING

    Memphis, Tennessee, 38104, United States

  • Butler Memorial Hospital

    RECRUITING

    Butler, Pennsylvania, 16001, United States

  • California Institute of Renal Research

    RECRUITING

    La Jolla, California, 92037, United States

  • First Coast Cardiovascular Institute Pa

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Houston Methodist

    RECRUITING

    Houston, Texas, 77030, United States

  • Kidney Care & Transplant Services of New England

    RECRUITING

    West Springfield, Massachusetts, 01089, United States

  • Kidney Care and Transplant Services of NE

    RECRUITING

    Springfield, Massachusetts, 01089, United States

  • NC Nephrology

    COMPLETED

    Raleigh, North Carolina, 27609, United States

  • ProMedica Toledo Hospital

    RECRUITING

    Toledo, Ohio, 43606, United States

  • Radiology and Imaging Specialists

    RECRUITING

    Lakeland, Florida, 33801, United States

  • San Francisco Vein & Vascular

    RECRUITING

    San Francisco, California, 94117, United States

  • Southern Adelaide Local Health Network

    RECRUITING

    Bedford Park, South Australia, 5042, Australia

  • UMass Chan School of Medicine

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Vascular Institute of Chattanooga

    RECRUITING

    Chattanooga, Tennessee, 37421, United States

  • Vascular and Spine Institute Inc

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33156, United States

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