An interventional study of ePATH System will be used to create an endoAVF in Kidney Disease, End-Stage, sponsored by Pathfinder Medical. Not yet recruiting at 1 site in Paraguay. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Pathfinder Medical · Not applicable, Interventional, and Device feasibility
The goal of this study is to evaluate the safety and effectiveness of the ePATH system in the creation of an endovascular AVF (endoAVF) in patients who require or will soon require hemodialysis and are eligible for a fistula.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 20 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →This is the only study on the registry with Pathfinder Medical as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An endoAVF will be created in the treated subjects.
Device: ePATH System will be used to create an endoAVF
An endoAVF will be created in subjects that need fistulas for hemodialysis
Primary Safety Endpoint
Proportion of patients that experience one or more serious ePATH device-related or ePATH portion of the procedure-related adverse events during the first 3 months following AVF creation.
Time frame: 3 months
Technical Success
Technical success: Successful creation of a fistula with the ePATH system. Verification that an endoAVF has been created with the ePATH system and that it remains patent 1-7 days after the index procedure. Patency will be defined by an experienced examiner as the presence of a bruit as detected by stethoscope, or the presence of a thrill, or with duplex ultrasonography for all study endpoints.
Time frame: 7 days
AVF maturation
Defined as an AVF that is free from stenosis or thrombosis with an arterial inflow of at least 500 ml/min and/or a diameter of at least 4 mm (as measured by duplex ultrasonography) or the patient was successfully dialysed with 2 needles.
Time frame: 3 months
Time to fistula maturation
Number of days between the index procedure and the date at which AVF maturation is achieved
Time frame: 3 months
Rate of other device or other procedure-related adverse events
Rate of serious other device (not ePATH device) or other procedure-related (not ePATH portion of the procedure) adverse events at 3 months following the index procedure
Time frame: 3 months
Rate of device and/or procedure related infections
Rate of device and/or procedure related infections at 3 months following the index procedure
Time frame: 3 months
Plan to share: No
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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