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Needle-Free blood vessel connection for dialysis patients tested

NCT ID NCT02682420

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device called everlinQ endoAVF that creates a connection between an artery and a vein using a thin tube (catheter) instead of open surgery. The goal was to make it easier for people with chronic kidney disease to get dialysis. The trial enrolled 100 adults who needed or were about to start dialysis. However, the study was stopped early, so we don't have full results on how well it worked.

What this could mean

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

Active substance
everlinQ endoAVF System (a device that creates a connection between an artery and vein using a catheter, avoiding open surgery)
What this could lead to
If successful, this device could provide a less invasive way to create dialysis access, potentially reducing surgery risks and recovery time.
What could go wrong
The trial was terminated early, so results are limited. The device may not work for all patients, and complications like clotting or narrowing of the fistula can still occur.

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

100 people

The number who actually took part.

Started

Sep 2016

Finished

Aug 2019

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: * Adult (age \>18 years old) * Currently on chronic dialysis or expected to be started on chronic dialysis within 3 months of planned endoAVF creation * Target treatment vein diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Venogram * Target treatment artery diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Arteriogram * Both radial and ulnar artery flow to the hand, as confirmed with Duplex Ultrasound and/or Allen's test (i.e.: palmar arch) Exclusion Criteria: * Known central venous stenosis or central vein narrowing \> 50% based on imaging on the same side as the planned AVF creation * Absence of perforator feeding the target cannulation vein(s) via Venogram * Occlusion or stenosis \>50% of target cannulation cephalic or basilic vein * Significantly compromised (≥50% stenosis) flow in the treatment arm * Documented ejection fraction (EF) ≤35% in the last 6 months * Pregnant women * New York Heart Association (NYHA) class III or IV heart failure * Hypercoagulable state * Known bleeding diathesis * Documented history of drug abuse including intravenous drugs within six months of AVF creation * "Planned" concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment * Known allergy to contrast dye which cannot be adequately pre-medicated * Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated * Evidence of active infections on the day of the index procedure * Estimated life expectancy \< 1 year * Patient is not willing to provide written informed consent, is not geographically stable and/or not willing to comply with required follow-up * Patient with a target cannulation vein that is \> 6mm deep that would require a transposition procedure, defined as the elevation of a target cannulation vein AND the creation of a new AV fistula * Patient is not willing to undergo a 2nd stage procedure as defined in Section 4.5.3 of the study protocol.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Dominikus Hospital

    Düsseldorf, Germany

  • Manchester University NHS Foundation Trust

    Manchester, M13 9WL, United Kingdom

  • Oxford University Hospitals - NHS Foundation Trust

    Headington, Oxford, OX3 9DU, United Kingdom

  • Providence Health Care Society

    Vancouver, British Columbia, V6Z 2K5, Canada

  • St. Franziskus-Hospital Münster

    Münster, Germany

  • St. George's University

    London, United Kingdom

  • University Hospital Carl Gustav Carus

    Dresden, Germany

  • University Hospitals Birmingham

    Birmingham, United Kingdom

  • University of Frankfurt

    Frankfurt, Germany

  • University of Leipzig

    Leipzig, Germany

  • University of Mannheim

    Mannheim, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.