PATH-03 Paraguay Feasibility Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Kidney Disease, End-Stage
• Intervention / Treatment: Device: ePATH System will be used to create an endoAVF

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sorin C Popa, BESc, MRes; Phone Number: +44 (0) 7939186529; Email: sorin@pathfindermed.com

Study Locations

• Paraguay
  • Asuncion, Paraguay, 001207
    • Sanatorio Italiano
    • Principal Investigator: Adrian A Ebner, MD
    • Contact: Adrian A Ebner, MD; Email: adrian@ebner.com.py

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 months
Time to fistula maturation	Number of days between the index procedure and the date at which AVF maturation is achieved	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	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	3 months

Collaborators and Investigators

• Sponsor: Pathfinder Medical
• Collaborators: MINSA SA
• Investigators: Principal Investigator: Adrian A Ebner, MD, Sanatorio Italiano

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 13, 2025
• First Submitted That Met QC Criteria: June 13, 2025
• First Posted (Actual): June 24, 2025

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: fistula, AVF, endoAVF, hemodialysis, vascular access; endovascular AVF
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: SKL-TF60000 10.4; Pathfinder Medical (Other Identifier: The study is funded only by Pathfinder Medical and is not listed in any other databases.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No