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

Last updated: February 17, 2025
Sponsor: Integra LifeSciences Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Hemorrhage

Treatment

CerebroFlo™ EVD Catheter

Clinical Study ID

NCT05113381
C-CERFLO-001
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject and/or legally authorized representative has reviewed the IRB- approvedconsent form, has been properly consented per the protocol and has documented theirconsent to participate in the study by signing the IRB-approved consent form.

  2. Subject is ≥ 18 years of age at the time of consent.

  3. Subjects with intraventricular hemorrhage (spontaneous primary IVH or secondary IVHdue to ruptured aneurysm) who have had CerebroFlo™ EVD Catheter(s) placed withoutcomplication.

  4. Subjects who require only one EVD Catheter at initial admission

Exclusion

Exclusion Criteria:

  1. Subjects with a scalp infection present.

  2. Subjects with uncorrectable coagulopathy due to prior administration ofanticoagulants at the time the CerebroFlo™ EVD Catheter(s) is placed.

  3. Subjects known to have a bleeding diathesis.

  4. Subjects in which the CerebroFlo™ EVD Catheter(s) is placed directly into a hematoma

  5. Evidence of catheter-associated hemorrhage from insertion of the CerebroFlo EVDCatheter(s) on post-placement CT scan.

  6. Subject is pregnant

Study Design

Total Participants: 109
Treatment Group(s): 1
Primary Treatment: CerebroFlo™ EVD Catheter
Phase:
Study Start date:
September 15, 2021
Estimated Completion Date:
August 30, 2025

Study 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.

Connect with a study center

  • Loma Linda University Health

    Loma Linda, California 92350
    United States

    Active - Recruiting

  • Stanford University

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • AdventHealth Orlando

    Orlando, Florida 32803
    United States

    Completed

  • Our Lady of the Lake Regional Medical Center

    Baton Rouge, Louisiana 70808
    United States

    Completed

  • Icahn School of Medicine at Mt. Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Wright State University/Premier Health

    Dayton, Ohio 45409
    United States

    Active - Recruiting

  • Medical City Plano

    Plano, Texas 75075
    United States

    Site Not Available

  • University of Texas Health Science Center

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • University of Utah Health

    Salt Lake City, Utah 84123
    United States

    Active - Recruiting

  • Virginia Commonwealth University Department of Neurosurgery

    Richmond, Virginia 23298
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.