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Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease

NCT01840956 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-08-19

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vascular Graft, HAVG.

The HAVG is intended as an alternative to synthetic materials and to autologous grafts in the creation of vascular access for dialysis.

Conditions

  • End-stage Renal Disease
  • Kidney Failure, Chronic

Interventions

BIOLOGICAL

HAVG

HAVG is implanted into patients' arm.

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • Aptiv Solutions

    collaborator INDUSTRY

  • Humacyte, Inc.

    lead INDUSTRY

Principal Investigators

  • Lynda H Szczech, MD, MSCE · Humacyte, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-23
Primary Completion
2016-04-28
Completion
2016-04-28

Countries

  • United States

Study Locations

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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 NCT01840956 on ClinicalTrials.gov