The University of Cincinnati Medical Center in the US is participating in a clinical trial for the ResQFoam device, which is designed to treat life-threatening internal abdominal bleeding.
The Reducing Exsanguination Via In-Vivo Expandable Foam (REVIVE) study involves multiple Level I Trauma Centers across the country.
Developed by Arsenal Medical with funding from the US Department of Defense, ResQFoam is an injectable biomaterial that expands within the abdomen to temporarily stop bleeding.
This device aims to provide a critical time for patients to reach surgery, where the foam can be readily removed.
The REVIVE study’s goal is to demonstrate the safety, effectiveness, and overall benefit-risk profile of ResQFoam for in-hospital use in patients suffering from severe internal abdominal bleeding and shock due to traumatic injuries.
Patients will be monitored for the first 30 days of their hospital stay to evaluate the device’s risks and benefits.
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Trauma physicians at UC Medical Center will identify potential candidates for the study, enrolling those deemed suitable.
UC Medical Center general surgery section chief and UC College of Medicine, department of surgery, trauma critical care and acute care surgery division professor Timothy Pritts is the principal investigator of the study.
Pritts said: “We hope to demonstrate that this foam can safely and effectively be used to help save lives, both in the hospital and on the battlefield.”
For those enrolled, treatment involves the injection of two liquid polymers that form an expanding foam upon contact, providing temporary bleeding control. Participants not in the study will receive the standard treatment for abdominal trauma.
In a departure from typical clinical trial protocols, emergency treatment with ResQFoam may commence without prior informed consent due to the urgent nature of the injuries. Efforts will be made to obtain consent from family members as soon as possible.
Patients have the option to opt out of the study by requesting an embossed wristband.
