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

End Stage Renal Disease Clinical Trial

Official title:
A Phase 2 Assessment of Humacyte's Human Acellular Vessel in Patients Needing Vascular Access for Dialysis

Clinical Trial Summary

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

Clinical Trial Description

This is a Phase 2, prospective, multicenter, open-label, single-arm study. Subjects who sign informed consent would undergo study-specific screening assessments within 45 days from the day of informed consent. Eligible study subjects will receive a HAV and will be followed to 12 months post-implantation at routine study visits regardless of patency status. After 12 months, subjects with a patent HAV will be followed (while the HAV remains patent) for up to 2 years (24 months) post implantation at study visits every 6 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04135417
Study type Interventional
Source Humacyte, Inc.
Contact
Status Completed
Phase Phase 2
Start date November 12, 2019
Completion date March 2, 2022
View Details
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