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Needle vs. scalpel: which dialysis access works best?

NCT ID NCT05654103

Disease control Sponsor: University of California, Los Angeles Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Updated 4 times

Summary

This study compares two methods for creating an arteriovenous fistula (AVF) in people with end-stage kidney disease who need dialysis. The newer endovascular method uses a needle through the skin, while the traditional surgical method requires an incision. Researchers will enroll 90 patients who qualify for both procedures and randomly assign them to one method, tracking how well the fistula matures and how long it lasts. The goal is to gather data for a larger study to determine which approach is better.

What this could mean

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

Active substance
endoAVF device and surgical AVF procedure
What this could lead to
If this trial succeeds, it could show that the newer needle-based method for creating dialysis access is as good as or better than surgery, potentially offering a less invasive option for kidney patients.
What could go wrong
This is a small pilot study with only 90 participants, so results may not apply to everyone. The newer method may require more follow-up procedures, and it's too early to know which approach is truly better.

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 90 people

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

Started

Nov 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 99 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: * ESKD patients aged ≥ 18 who have chosen hemodialysis as their renal replacement option. * Ability to give consent to participate in a research study. * Upper arm vein diameter of ≥ 2.0 mm. Ellipsys specific inclusion criteria: * Confirmed radial artery-adjacent vein proximity ≤ 1.5 mm measured lumen edge-to-lumen edge as determined by preprocedural ultrasound and confirmed pre-procedurally. * Confirmed radial artery and adjacent vein diameter of ≥ 2.0 mm at site where vein and artery connects. WavelinQ specific inclusion criteria: * Target vein diameter ≥ 2.0 mm, target artery diameter ≥ 2.0 mm, and ≤ 2 mm between target artery and vein. Exclusion Criteria: * People under the age of 18. * Inability to understand the consent process and/or give consent. * Upper arm vein diameter less than 2.0 mm making them unsuitable to receive an surgAVF AND endoAVF. * Patients who are deemed by the surgeon to be anatomic candidates for a forearm vascular access, and the surgeon and the patient determine that a forearm access is the optimal access for the patient, in order to preserve more proximal anatomic sites for future accesses. * Currently incarcerated individuals. * Currently pregnant or planning to get pregnant within the next 6 months. * Individuals who choose peritoneal dialysis over hemodialysis and/or undergoing a kidney transplant within 6 months of randomization.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease congenital arteriovenous fistula end stage renal failure Fistula

As listed by the trial registrant

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

End stage renal disease on dialysis

Contacts and locations

Locations

  • UCLA Division of Vascular and Endovascular Surgery Clinic

    Los Angeles, California, 90095, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15231, United States

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