Magnetic catheter could simplify dialysis access for kidney patients
NCT ID NCT03708562
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
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24 people
The number who actually took part.
- Started
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Oct 2017
- Finished
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Dec 2018
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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