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

  • End date
    Dec 30, 2023
  • participants needed
  • sponsor
    Integra LifeSciences Corporation
Updated on 16 October 2022


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).


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.

Condition Intraventricular Hemorrhage, Subarachnoid Hemorrhage
Treatment CerebroFlo™ EVD Catheter
Clinical Study IdentifierNCT05113381
SponsorIntegra LifeSciences Corporation
Last Modified on16 October 2022


Yes No Not Sure

Inclusion Criteria

Subject and/or legally authorized representative has reviewed the IRB- approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the IRB-approved consent form
Subject is ≥ 18 years of age at the time of consent
Subjects with intraventricular hemorrhage (spontaneous primary IVH or secondary IVH due to ruptured aneurysm) who have had CerebroFlo™ EVD Catheter(s) placed without complication
Subjects who require only one EVD Catheter at initial admission

Exclusion Criteria

Subjects with a scalp infection present
Subjects with uncorrectable coagulopathy due to prior administration of anticoagulants at the time the CerebroFlo™ EVD Catheter(s) is placed
Subjects known to have a bleeding diathesis
Subjects in which the CerebroFlo™ EVD Catheter(s) is placed directly into a hematoma
Evidence of catheter-associated hemorrhage from insertion of the CerebroFlo EVD Catheter(s) on post-placement CT scan
Subject is pregnant
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Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If 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.

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Complete 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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