Safety and Efficacy Assessment of HAV (Manufactured Using Large-scale System) in Patients Needing Vascular Access for Dialysis
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- End Stage Renal Disease
- Hemodialysis
- Renal Failure
- Vascular Access
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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-implanta...
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 3 years (36 months) post implantation at study visits every 6 months.
Tracking Information
- NCT #
- NCT04135417
- Collaborators
- Not Provided
- Investigators
- Study Director: Kiernan DeAngelis, MD Humacyte, Inc.
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