Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-31 @ 3:05 PM
Study NCT ID:
NCT05873959
Status:
COMPLETED
Last Update Posted:
2024-11-25
First Post:
2023-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study to Evaluate the Safety and Efficacy of Humacyte's HAV for Arterial Replacement or Reconstruction in Ukrainian Patients With Life or Limb-threatening Vascular Trauma
Sponsor:
Humacyte, Inc.
Organization:
Study Overview
Official Title:
An Observational Multicenter Study to Evaluate the Safety and Efficacy of Humacyte's Human Acellular Vessel in a Real World Setting for Arterial Replacement or Reconstruction in Ukrainian Patients With Life or Limb-threatening Vascular Trauma
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03631056
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
None
Brief Summary:
Humacyte provided HAVs as humanitarian aid to Ukraine. This retrospective observational study is designed to collect data from patients in whom the HAVs have already been implanted on a humanitarian basis between June 2022 and May 2023.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: