REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Arsenal Medical, Inc.
Study ID
NCT02880163
Status
Recruiting
Apply to this trial

Conditions

  • Exsanguinating Hemorrhage
  • Hemorrhagic Shock
  • Shock; Traumatic
  • Trauma

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ResQFoam — DEVICE
    Hemostatic device for the treatment of emergent, exsanguinating, Class III or IV intraabdominal hemorrhagic shock in subjects due to trauma

Study Details

The purpose of this study is to demonstrate safety, effectiveness and benefit-risk profile of ResQFoam for the inhospital treatment of exsanguinating, intraabdominal haemorrhage due to trauma in patients where emergent laparotomy is required.

Key Dates

Start date
Aug 7, 2025
Status verified
Nov 2025
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ResQFoam
    ResQFoam in-vivo expandable foam

Primary Outcome Measure

Change in systolic blood pressure after deployment of ResQFoam over baseline value [ Time Frame: All SBP assessments prior to deployment of IP through removal of IP and completion of laparotomy. Patient will be followed through hospital discharge or through Day 30, whichever comes first. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Madison Finch
[email protected]
205-873-3652
William P Hewgley, MD (PRINCIPAL_INVESTIGATOR)
University of CincinnatiCincinnatiOhio45219
Dina Gomaa, MSc
[email protected]
513-558-6305
Timothy Pritts, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of Cincinnati· Cincinnati, OH

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