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First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft

NCT04898153 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-10

No results posted yet for this study

Summary

A feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.

Conditions

Interventions

DEVICE

aXess

Patients will be implanted with one Xeltis hemodialysis access device (aXess) in the arm

Sponsors & Collaborators

  • Xeltis

    lead INDUSTRY

Principal Investigators

  • Frank Vermassen, MD · UZ Ghent

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-10
Primary Completion
2023-03-24
Completion
2027-09-30

Countries

  • Belgium
  • Italy
  • Latvia
  • Lithuania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04898153 on ClinicalTrials.gov