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Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis

NCT04135417 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-03-19

Study results available
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Summary

This is a Phase 2, prospective, multicenter, open-label, single-arm study of the Human Acellular Vessel (HAV).

Conditions

Interventions

BIOLOGICAL

HAV

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

Sponsors & Collaborators

  • Humacyte, Inc.

    lead INDUSTRY

Principal Investigators

  • Shamik Shamik, MD · Humacyte, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-12
Primary Completion
2021-05-15
Completion
2022-03-02
FDA Drug
Yes

Countries

  • Poland

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 NCT04135417 on ClinicalTrials.gov