NCT02880163

REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

Reducing Exsanguination Via In-Vivo Expandable Foam

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Arsenal Medical, Inc. · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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

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

Timeline

• Start date: 2025-08-07
• Primary completion: 2026-10-31
• Completion: 2026-12-31
• First posted: 2016-08-26
• Last updated: 2025-11-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study