Nico Corp said today it enrolled the 1st patient in the Enrich clinical trial which aims to explore the use of its BrainPath Approach for treating intracerebral hemorrhages.
The trial will examine the procedural safety as well as economic and functional benefit of early surgical removal of intracerebral hemorrhages using its BrainPath Approach system.
“Our initial clinical results with this approach for early clot removal have been exciting and provided a wake-up call to what has been missing in hemorrhagic stroke care,” trial principal investigator Dr. Daniel Barrow said in a press release.
Indianapolis, Ind.-based Nico said it hopes to enroll 300 spontaneous supratentorial ICH patients in the trial at 15 trial sites as it studies the system.
“We are seeing encouraging results with our patients and added economic benefit to our hospital. This trial will help us determine in a scientifically valid manner if a precise surgical technique to avoid additional injury to the brain and early evacuation of blood contributes to improved clinical and functional outcomes,” study principal investigator Dr. Gustavo Pradilla said in a prepared statement.
The Enrich trial will compare the standard of care, which is medical management of the siituation, to early surgical evacuation using a parafascicular and trans-sulcal surgical approach for clot removal and hemostasis.
“Scientific evidence from prospective and retrospective studies has produced strong clinical data from prestigious academic and community centers showing that successful surgical treatment for ICH can and does exist. We have created groundbreaking technologies used in the trial that create navigation-compatible access to the brain in a way that’s never been done before. What we are most excited about is the possibility of showing functional recovery in this very deadly and costly disease state,” Nico prez & CEO Jim Pearson said in a prepared release.
“The idea of including multi-disciplinary teams benefits patients and study subjects enrolled in the trial by ensuring exceptional execution of the clinical trial along with delivering the highest quality care in a well-coordinated fashion. This alone comforts a lot of families and provides a foundation of hope for a better outcome for their loved one,” co-principal investigator Dr. Jonathan Ratcliff said in prepared remarks.