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Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study

NCT06329310 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-04

No results posted yet for this study

Summary

A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation.

Conditions

Interventions

DEVICE

aXess-E conduit

The aXess-E conduit is a sterile, regenerative biodegradable polymer-based vascular conduit, consisting of a tubular structure with a 6mm inner diameter. It is comprised of a highly porous polymer matrix and an embedded electropolished nitinol reinforcement layer (Strain Relief System). The aXess-E conduit is able to support both straight and loop configurations and may be implanted in the upper arm and forearm.

Sponsors & Collaborators

  • Xeltis

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-16
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Portugal
  • Serbia

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 NCT06329310 on ClinicalTrials.gov