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PATH-03 Paraguay Feasibility Study | Clinical Trials | Clareo Health

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PATH-03 Paraguay Feasibility Study

Feasibility Study to Evaluate the Safety and Efficacy of the ePATH System for endoAVF Creation

NCT07034092•Pathfinder Medical

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

Locations (1)

Sanatorio Italiano

Asunción, Paraguay

Key Dates

Start Date

October 1, 2025

Primary Completion Date

June 1, 2026

Completion Date

October 1, 2026

Last Updated

July 17, 2025

Enrollment

ESTIMATED participants

Conditions

Kidney Disease, End-Stage

Interventions

ePATH System will be used to create an endoAVF

DEVICE

Contacts

Sorin C Popa, BESc, MRes

CONTACT

+44 (0) 7939186529 sorin@pathfindermed.com

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

NCT04634916

Kidney Disease, End-StageEnd-stage Renal Disease+1 more

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RECRUITING

Rutgers University Study of the Genetics of Kidney Disease

NCT07217535

Kidney DiseaseKidney Disease, Chronic+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PATH-03 Paraguay Feasibility Study

Inclusion Criteria

Exclusion Criteria

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

Rutgers University Study of the Genetics of Kidney Disease

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Electronic Patient-Reported Outcomes in Clinical Kidney Practice (ePRO Kidney)

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