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

Last updated: November 21, 2024
Sponsor: Humacyte, Inc.
Overall Status: Completed

Phase

N/A

Condition

Hyponatremia

Treatment

HAV implantation

Clinical Study ID

NCT05873959
CLN-PRO-V017
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with an HAV implanted to repair or reconstruct an arterial vessel followinglife- or limb-threatening traumatic vascular injury of an extremity.

  • Aged 18 to 85 years old, inclusive.

  • Patient or legal representative is able, willing, and competent to give informedconsent.

Exclusion

Exclusion Criteria:

• Employees of the sponsor or patients who are employees or relatives of the investigator.

Study Design

Total Participants: 17
Treatment Group(s): 1
Primary Treatment: HAV implantation
Phase:
Study Start date:
May 01, 2023
Estimated Completion Date:
January 15, 2024

Connect with a study center

  • Municipal Non-Profit Enterprise ""City Clinical Hospital #16" of the Dnipro City Council"

    Dnipro,
    Ukraine

    Site Not Available

  • Medical Center LLC "CLINIC VERUM EXPERT"

    Kyiv,
    Ukraine

    Site Not Available

  • Communal non-profit enterprise "Vinnytsia Regional Clinical Hospital named after E. Pirogov" of the Vinnytsia Regional Council, center of cardiovascular surgery

    Vinnytsia,
    Ukraine

    Site Not Available

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