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NCT03005418 · ClinicalTrials.gov registry record · Phase 2
Humacyte Human Acellular Vessel (HAV) in Patients With Vascular Trauma
A Phase 2 study of Trauma and Vascular System Injury, sponsored by Humacyte.
- Active
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 20
- Study locations
NCT03005418: Active Phase 2 study of Trauma and Vascular System Injury, sponsored by Humacyte.
NCT03005418 is a Phase 2 study of Trauma and Vascular System Injury that is active but no longer recruiting, run by Humacyte. The registered enrollment target is 72 participants, below the 306-participant average among 56 other Trauma trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03005418, a Phase 2 study of Trauma and Vascular System Injury, is active but no longer recruiting, sponsored by Humacyte.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study evaluates the use of the Human Acellular Vessel (HAV) in adults with vascular trauma below the neck who are undergoing vascular reconstructive surgery. There will be a torso cohort and a limb cohort. All subjects will be implanted with a HAV as an interposition vessel or bypass using standard vascular surgical techniques. There is no control arm.
Primary Outcome
Rate of primary patency at the specified milestone post-implantation, evaluated across the entire overall study population who received the Human Acellular Vessel (HAV). Primary patency is defined as the continuous presence of blood flow through the HAV conduit from the time of surgical placement until the evaluation milestone, without requiring any intervening surgical or endovascular interventions to maintain or re-establish flow.
Conditions Studied
Interventions
- BIOLOGICAL Human Acellular Vessel (HAV)
Study Locations (20)
California
- Jacob Medical Center at UC San Diego - La Jolla
- Keck Hospital of University of Southern California (USC) - Los Angeles
- Cedars-Sinai Medical Cener - Los Angeles
- UCI Medical Center - Orange
- University California, Davis - Sacramento
- University of California San Diego (UCSD) Medical Center - San Diego
Florida
- UF Health Jacksonville - Jacksonville
- Jackson South Medical Center - Miami
- Ryder Trauma Center - Miami
- Tampa General Hospital - Tampa
Maryland
- R Adams Cowley Baltimore Shock Trauma - Baltimore
- Johns Hopkins Bayview Medical Center - Baltimore
- Johns Hopkins Hospital - Baltimore
New Jersey
- Cooper University Hospital - Camden
- Rutgers New Jersey Medical School - Newark
Colorado
- Ernest E Moore Shock Trauma Center at Denver Health - Denver
Georgia
- Grady Memorial Hospital - Atlanta
Minnesota
- Mayo Clinic - Rochester
Missouri
- Saint Louis University (SLU) - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2018-09-01 |
| Est. Completion | 2027-09-01 |
| Phase | Phase 2 |
What the registry record for NCT03005418 still lists
NCT03005418 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 306-participant average among 56 other Trauma trials with a reported enrollment target (76% lower).
The record links to 2 conditions, with Trauma appearing as the primary indexed condition, and to 1 intervention - of which Human Acellular Vessel (HAV) is the first listed.
NCT03005418 names 20 study sites across 9 states, led by California, Florida, Maryland.
Frequently Asked Questions
What is clinical trial NCT03005418 about?
NCT03005418 is a clinical study titled "Humacyte Human Acellular Vessel (HAV) in Patients With Vascular Trauma". This study evaluates the use of the Human Acellular Vessel (HAV) in adults with vascular trauma below the neck who are undergoing vascular reconstructive surgery. There will be a torso cohort and a limb cohort. All subjects will be implanted with a HAV as an interposition vessel or bypass using stan...
What is the current status of trial NCT03005418?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2018-09-01. Estimated completion is 2027-09-01.
What conditions does trial NCT03005418 study?
This clinical trial studies the following conditions: Trauma, Vascular System Injury.
What interventions are being tested in trial NCT03005418?
The interventions under investigation include: Human Acellular Vessel (HAV) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03005418?
This trial is sponsored by Humacyte, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03005418 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03005418's enrollment target sits among peer trials
72 36th of 56 higher than 21 of 56 other Trauma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Trauma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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