PATH-03 Paraguay Feasibility Study

NCT ID: NCT07034092

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2026-10-31

Brief 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.

Conditions

Kidney Disease, End-Stage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Intervention group

An endoAVF will be created in the treated subjects.

Group Type: EXPERIMENTAL

ePATH System will be used to create an endoAVF

Intervention Type: DEVICE

An endoAVF will be created in subjects that need fistulas for hemodialysis

Interventions

ePATH System will be used to create an endoAVF

An endoAVF will be created in subjects that need fistulas for hemodialysis

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MINSA SA

UNKNOWN

Sponsor Role: collaborator

Pathfinder Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian A Ebner, MD

Role: PRINCIPAL_INVESTIGATOR

Sanatorio Italiano

Locations

Sanatorio Italiano

Asunción, , Paraguay

Countries

Paraguay

Central Contacts

Sorin C Popa, BESc, MRes

Role: CONTACT

sorin@pathfindermed.com

+44 (0) 7939186529

Facility Contacts

Adrian A Ebner, MD

Role: primary

adrian@ebner.com.py

Other Identifiers

Pathfinder Medical

Identifier Type: OTHER

Identifier Source: secondary_id

SKL-TF60000 10.4

Identifier Type: -

Identifier Source: org_study_id