The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of IVH
Launched by INTEGRA LIFESCIENCES CORPORATION · Oct 28, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effectiveness of a device called the CerebroFlo™ EVD Catheter in treating a condition known as intraventricular hemorrhage (IVH), which is bleeding in the brain's ventricles. The main focus is to see how often doctors need to flush the catheter to keep it working properly and prevent blockages during treatment. The trial is currently looking for participants who are 18 years or older and have had this catheter placed without any complications.
To be eligible for the study, potential participants should be experiencing IVH, either from a spontaneous cause or due to a ruptured aneurysm, and only need one catheter placed during their hospital stay. However, some individuals may not qualify, such as those with certain infections, bleeding disorders, or if the catheter was placed directly into a blood clot. If you or a loved one might be interested in joining this trial, it could provide valuable information about a treatment option for IVH and help improve care for future patients.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. 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.
- • 2. Subject is ≥ 18 years of age at the time of consent.
- • 3. Subjects with intraventricular hemorrhage (spontaneous primary IVH or secondary IVH due to ruptured aneurysm) who have had CerebroFlo™ EVD Catheter(s) placed without complication.
- • 4. Subjects who require only one EVD Catheter at initial admission
- Exclusion Criteria:
- • 1. Subjects with a scalp infection present.
- • 2. Subjects with uncorrectable coagulopathy due to prior administration of anticoagulants 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 EVD Catheter(s) on post-placement CT scan.
- • 6. Subject is pregnant
About Integra Lifesciences Corporation
Integra LifeSciences Corporation is a leading global medical technology company specializing in regenerative medicine and neurosurgery. With a commitment to innovation and excellence, Integra develops a diverse range of advanced technologies and products designed to improve patient outcomes in areas such as tissue regeneration, surgical reconstruction, and advanced wound care. The company is dedicated to supporting healthcare professionals through clinical trials that aim to validate the safety and efficacy of its cutting-edge solutions, ultimately enhancing the quality of care for patients worldwide. Integra’s focus on research and development, coupled with its robust portfolio, positions it as a key player in the medical device industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Palo Alto, California, United States
Orlando, Florida, United States
San Antonio, Texas, United States
Baton Rouge, Louisiana, United States
Loma Linda, California, United States
Aurora, Colorado, United States
New York, New York, United States
Plano, Texas, United States
Dayton, Ohio, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Patients applied
Trial Officials
Ramesh Grandhi, MD
Principal Investigator
University of Utah Health
Jason Marzuola, MSN
Study Director
Integra Life Sciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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