MedTrace Logo

Evaluation of STARgraft-2 for Hemodialysis Access

NCT04783779 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-02-28

No results posted yet for this study

Summary

This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-2 hemodialysis access graft. STARgraft devices have been demonstrated in preclinical and other studies to have improved resistance to the common failure modes of venous anastomosis stenosis and infection.

This study is an extension from a prior First in Human (FIH) study (NCT03916731) with the STARgraft AV investigational device. That study also included control implants of commercially available standard ePTFE grafts approved for the same use.

The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to:

1. Evaluate the performance of the investigational STARgraft-2 compared to the ePTFE controls in the prior study and to published results, over a period of 6 months, with extended results to 1 year.
2. Verify safety of the STARgraft-2 multilayer construction in extended dialysis vascular access use.

It is intended to enroll 25 subjects in this study.

Conditions

Interventions

DEVICE

Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access

After healing from the surgical procedure the graft will be routinely cannulated for hemodialysis sessions. Periodic evaluations of blood flow by ultrasound imaging will be made over the study period. Established standards of care will be followed as needed to maintain dialysis function.

Sponsors & Collaborators

  • Healionics Corporation

    lead INDUSTRY

Principal Investigators

  • Adrian Ebner, MD · Italian Hospital Asuncion Paraguay

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-16
Primary Completion
2022-06-01
Completion
2023-10-31
FDA Device
Yes

Countries

  • Paraguay

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 NCT04783779 on ClinicalTrials.gov