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Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis

NCT03183245 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2025-11-20

No results posted yet for this study

Summary

The main purpose of this study is to compare the Human Acellular Vessel (HAV) with arteriovenous fistula (AVF) when used for hemodialysis access

Conditions

Interventions

BIOLOGICAL

Human Acellular Vessel (HAV)

Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.

PROCEDURE

Arteriovenous fistula (AVF)

Surgical creation of an autologous arteriovenous fistula and subsequent use of the implanted vascular conduit for hemodialysis vascular access.

OTHER

Hemodialysis

Procedure that filters a person's blood when their kidneys are no longer functioning properly

Sponsors & Collaborators

  • CTI Clinical Trial and Consulting Services

    collaborator OTHER

  • California Institute for Regenerative Medicine (CIRM)

    collaborator OTHER

  • Humacyte, Inc.

    lead INDUSTRY

Principal Investigators

  • Shamik Parikh, MD · Humacyte, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-29
Primary Completion
2024-04-22
Completion
2025-06-19
FDA Drug
Yes

Countries

  • United States

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 NCT03183245 on ClinicalTrials.gov