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Magnetic catheter could simplify dialysis access for kidney patients

NCT ID NCT03708562

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 2 times

Summary

This study tested a new device called the everlinQ endoAVF System in 24 adults with kidney failure who need dialysis. The device uses magnets and radiofrequency energy to create a connection between an artery and a vein, providing a way to access the blood for dialysis. The goal was to see if this less invasive method could work safely and effectively, potentially offering more options for patients.

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 uses magnets and radiofrequency energy to create a connection between an artery and a vein)
What this could lead to
If successful, this device could offer a less invasive way to create dialysis access, potentially reducing complications and recovery time for kidney failure patients.
What could go wrong
This was a small, early study with only 24 participants, so results may not apply to everyone. The device may not work as well in real-world settings, and there are risks like infection or blood clots.

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

24 people

The number who actually took part.

Started

Oct 2017

Finished

Dec 2018

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. Eligible for a native arteriovenous fistula. 2. Adult (age \>18 years old). 3. Established, non-reversible kidney failure requiring hemodialysis (including pre-dialysis patients). 4. Target vein diameter(s) at fistula site ≥ 2.0 mm. 5. Target artery diameter at fistula site ≥ 2.0 mm. 6. Procedural access site artery and vein diameter ≥ 2.0 mm. 7. At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the perforating vein. 8. Estimated life expectancy \> 1 year. 9. Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure. 10. Presence of an antecubital perforating vein diameter ≥ 2.0 mm. Exclusion Criteria: 1. Known central venous stenosis or central vein narrowing \> 50% based on imaging on the same side as the planned AVF creation. 2. Upper extremity venous occlusion(s) and/or vessel abnormality(ies) on the same side as the planned AVF creation that precludes endovascular AVF creation by the everlinQ System as deemed by the interventionalists' clinical judgment. 3. Prior surgically created access in the planned treatment location. 4. Functioning surgical access in the planned treatment arm. 5. Pregnant women. 6. New York Heart Association (NYHA) class III or IV heart failure. 7. Hypercoagulable state. 8. Known bleeding diathesis. 9. Immunosuppression, defined as use of immunosuppressive medications used to treat an active condition. 10. Documented history of drug abuse including intravenous drugs within six months of AVF creation. 11. "Planned" concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment. 12. Currently being treated with another investigational device or drug. 13. Known allergy to contrast dye which cannot be adequately pre-medicated. 14. Known adverse effects to sedation and/or anesthesia which cannot be adequately pre- medicated. 15. Patients who do not have an ulnar or radial artery. 16. Distance between target artery and vein or other anatomical abnormality will not permit catheters to be introduced, navigated to fistula site, or allow magnets to align vessels sufficiently to create the fistula. 17. Evidence of calcification in vessels at the fistula site. 18. Evidence of active infections on the day of the index procedure. 19. Written informed consent not obtained.

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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

  • Sanatorio Italiano

    Asunción, Paraguay

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