Device aims to build dialysis access from inside the blood vessels
NCT ID NCT07034092
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
People with end-stage kidney disease need a reliable blood vessel connection, called a fistula, for hemodialysis. This study tests a device called the ePATH System, which creates that connection from inside the blood vessels rather than through open surgery. Researchers will follow about 20 adults who need or will soon need dialysis to see whether the procedure is safe and whether the fistula works in the first few months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- The ePATH System, a device that creates a fistula between an artery and a vein from inside the blood vessels
- What this could lead to
- If it works, this could offer a less invasive way to create the vascular access people with kidney failure need for dialysis.
- What could go wrong
- This is a small feasibility study, so it can only show whether the approach is safe enough and works technically in a few patients. The fistula may fail to stay open, or the device could cause complications.
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
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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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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2027
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- 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. Patients deemed eligible for creation of an AV fistula according to institutional or local guidelines and/or clinical judgement of the investigator 2. Adults (age \>18 years old) 3. Non-reversible kidney failure requiring hemodialysis (this can include pre-dialysis patients) 4. Target vein diameter of ≥2.0 mm 5. Target artery diameter of ≥2.0 mm 6. Both radial and ulnar artery flow to the hand, confirmed with Duplex Ultrasound and/or Allen's test (i.e. palmar arch) 7. Able to provide informed consent 8. Able to comply with follow-up visit assessment requirements 9. Patient is free from clinically significant conditions or illnesses that might compromise the procedure or the AVF Exclusion Criteria: 1. Significant central venous stenosis or narrowing that exceeds 50% based on imaging 2. Hypercoagulable state or known bleeding diathesis 3. NHYA Class III or IV heart failure 4. Estimated life-expectancy of \<1 year based on the physician's opinion 5. Oedema of extremities 6. Current diagnosis of carcinoma 7. Pregnant or breastfeeding women 8. Diagnosed or suspected skin disease at the access site 9. Immunosuppression or otherwise immunocompromised patients 10. Currently being treated with another investigational device or medication 11. Allergy to contrast or other drugs associated with surgery, e.g., sedation agents, or to device materials 12. Anatomy that prevents formation of AVF, e.g., misalignment of vessels or tortuosity 13. Patient is unwilling to undergo 2nd stage procedure, e.g. endovascular prothesis placement or balloon dilatation, if required
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Sanatorio Italiano
Asunción, 001207, Paraguay
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