CompletedNot Applicable

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

United States105 participantsStarted 2021-09-15

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subject and/or legally authorized representative has reviewed the Institutional Review Board (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

What they're measuring

Number of flushing interventions to address occlusions

Timeframe: study device implantation through study device removal

Trial details

NCT IDNCT05113381

SponsorIntegra LifeSciences Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-31

View on ClinicalTrials.gov More Intraventricular Hemorrhage trials