Kidney Disease, End-StageNCT07034092
PATH-03 Paraguay Feasibility Study
A study testing ePATH System will be used to create an endoAVF in people with Kidney Disease, End-Stage, run by Pathfinder Medical at 1 site in Paraguay.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Disease, End-Stage
- What is being tested?
- ePATH System will be used to create an endoAVF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteParaguay
- Study dates
- Mar 2027to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients deemed eligible for creation of an AV fistula according to institutional or local guidelines and/or clinical judgement of the investigator
- Adults (age >18 years old)
- Non-reversible kidney failure requiring hemodialysis (this can include pre-dialysis patients)
- Target vein diameter of ≥2.0 mm
- Target artery diameter of ≥2.0 mm
- Both radial and ulnar artery flow to the hand, confirmed with Duplex Ultrasound and/or Allen's test (i.e. palmar arch)
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- Able to provide informed consent
- Able to comply with follow-up visit assessment requirements
- Patient is free from clinically significant conditions or illnesses that might compromise the procedure or the AVF
Who cannot join
- Significant central venous stenosis or narrowing that exceeds 50% based on imaging
- Hypercoagulable state or known bleeding diathesis
- NHYA Class III or IV heart failure
- Estimated life-expectancy of <1 year based on the physician's opinion
- Oedema of extremities
- Current diagnosis of carcinoma
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- Pregnant or breastfeeding women
- Diagnosed or suspected skin disease at the access site
- Immunosuppression or otherwise immunocompromised patients
- Currently being treated with another investigational device or medication
- Allergy to contrast or other drugs associated with surgery, e.g., sedation agents, or to device materials
- Anatomy that prevents formation of AVF, e.g., misalignment of vessels or tortuosity
- Patient is unwilling to undergo 2nd stage procedure, e.g. endovascular prothesis placement or balloon dilatation, if required
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Paraguay1 site
Sanatorio Italiano
Asunción, 001207
Adrian A Ebner, MD, adrian@ebner.com.py
Adrian A Ebner, MD
About this study
Official title: Feasibility Study to Evaluate the Safety and Efficacy of the ePATH System for endoAVF Creation
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.
- Conditions
- Kidney Disease, End-Stage
- Being tested
- ePATH System will be used to create an endoAVF
- Keywords
- fistula, AVF, endoAVF, hemodialysis, vascular access, endovascular AVF
- Medical subject headings
- Kidney Failure, Chronic, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePATH System will be used to create an endoAVFDevice
An endoAVF will be created in subjects that need fistulas for hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | An endoAVF will be created in the treated subjects. Receives: Device: ePATH System will be used to create an endoAVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 3 months
Time to fistula maturation
Number of days between the index procedure and the date at which AVF maturation is achieved
Measured: 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
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study startMar 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Disease, End-StageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An endoAVF for dialysis access will be created in the treated subjects.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pathfinder Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MINSA SA
- Responsible party
- Sponsor
- Investigators
- Adrian A Ebner, MD, Principal investigator, Sanatorio Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034092
- Sponsor's protocol ID
- SKL-TF60000 10.4
- Other IDs
- Pathfinder Medical
- Status last verified
- Sep 2026
- First submitted
- 13 Jun 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Evaluate the Safety and Efficacy of the ePATH System for endoAVF Creation
- ClinicalTrials.gov ID
- NCT07034092
- Acronym / sponsor ID
- SKL-TF60000 10.4
- Conditions
- Kidney Disease, End-Stage
- Keywords
- fistula, AVF, endoAVF, hemodialysis, vascular access, endovascular AVF
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pathfinder MedicalIndustry (pharma, biotech, devices)
- Collaborators
- MINSA SA
- Study start
- Mar 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An endoAVF for dialysis access will be created in the treated subjects.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: ePATH System will be used to create an endoAVFAn endoAVF will be created in the treated subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients deemed eligible for creation of an AV fistula according to institutional or local guidelines and/or clinical judgement of the investigator
- Adults (age >18 years old)
- Non-reversible kidney failure requiring hemodialysis (this can include pre-dialysis patients)
- Target vein diameter of ≥2.0 mm
- Target artery diameter of ≥2.0 mm
Key exclusion criteria (13 listed)
- Significant central venous stenosis or narrowing that exceeds 50% based on imaging
- Hypercoagulable state or known bleeding diathesis
- NHYA Class III or IV heart failure
- Estimated life-expectancy of <1 year based on the physician's opinion
- Oedema of extremities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ePATH System will be used to create an endoAVFAn endoAVF will be created in subjects that need fistulas for hemodialysis | Device | Intervention group |
Primary outcome
Primary Safety Endpoint
Time frame: 3 months
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.
5 secondary outcomes
Technical Success
Time frame: 7 days
AVF maturation
Time frame: 3 months
Time to fistula maturation
Time frame: 3 months
Rate of other device or other procedure-related adverse events
Time frame: 3 months
Rate of device and/or procedure related infections
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adrian A Ebner, MD principal investigator
Sanatorio Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePATH System will be used to create an endoAVF in people with Kidney Disease, End-Stage, run by Pathfinder Medical at 1 site in Paraguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sorin C Popa, BESc, MRes (+44 (0) 7939186529, sorin@pathfindermed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.