A Prospective, Multicenter Study to Evaluate the Performance and Safety of the CerebroFlo™ EVD Catheter
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- STATUS
- Recruiting
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- End date
- Dec 30, 2023
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- participants needed
- 109
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- sponsor
- Integra LifeSciences Corporation
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).
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.
Details
| Condition | Intraventricular Hemorrhage, Subarachnoid Hemorrhage |
|---|---|
| Treatment | CerebroFlo™ EVD Catheter |
| Clinical Study Identifier | NCT05113381 |
| Sponsor | Integra LifeSciences Corporation |
| Last Modified on | 16 October 2022 |
How to participate?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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