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REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

NCT02880163 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-10

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

ResQFoam

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

Sponsors & Collaborators

  • Arsenal Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Timothy Pritts, MD · University of Cincinnati

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-07
Primary Completion
2026-10-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02880163 on ClinicalTrials.gov