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The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of IVH

Subarachnoid Hemorrhage Clinical Trial

Official title:
A Prospective, Multicenter Study to Evaluate the Performance and Safety of the CerebroFlo™ EVD Catheter

Clinical Trial Summary

The primary goal of this study is to assess the occurrence of flushing interventions to address occlusions during the treatment of interventricular hemorrhage (spontaneous primary IVH or secondary IVH due to ruptured aneurysm).

Clinical Trial Description

Potential study candidates will be screened for inclusion and exclusion criteria after informed consent has been provided by the Legally Acceptable Representative and/or the study candidate. Once enrolled in the study, data will be collected from those subjects with elevated intracranial pressure (ICP), interventricular hemorrhage, or hydrocephalic shunt infections as a result of the use of the EVD catheter. Pre-insertion and peri-removal CT scans and neurological assessment data will also be collected. Data will be collected for subjects beginning from the time of hospital admission through discharge and followed by the 30 Day and 90 Day Follow up Visits. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05113381
Study type Interventional
Source Integra LifeSciences Corporation
Contact Andrew Tummon
Phone 609-936-5490
Email andrew.tummon@integralife.com
Status Recruiting
Phase N/A
Start date September 15, 2021
Completion date December 30, 2024
View Details
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