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

NCT05113381 | Completed FDA Device

• 1 other identifier: C-CERFLO-001
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 10

Brief 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).

Conditions

Intraventricular Hemorrhage; Subarachnoid Hemorrhage

Keywords

interventricular hemorrhage

Outcome Measures

Primary Outcomes (1)

• Number of flushing interventions to address occlusions

  The number of flushing interventions from initial catheter placement through catheter removal, an average of 10 days, to address occlusions.

  study device implantation through study device removal

Secondary Outcomes (4)

• Change of hemorrhage volume

  Device implantation through to 90-Day follow-up

• Assessment of Glasgow Coma Score (GCS)

  Device implantation through to 90-Day follow-up

• Assessment of Modified Rankin Score (mRS)

  Device implantation through to 90-Day follow-up

• Assessment of National Institute of Health Stroke Scale (NIHSS)

  Device implantation through to 90-Day follow-up

Study Arms (1)

Intraventricular Hemorrhage Subjects

EXPERIMENTAL

Intervention: Cerebrospinal Fluid (CSF) reduction Extra Ventricular Drainage (EVD) catheters will be used for cerebrospinal fluid drainage

Device: CerebroFlo™ EVD Catheter

Interventions

CerebroFlo™ EVD Catheter DEVICE

The CerebroFlo™ EVD Catheter is indicated for temporary insertion into a ventricular cavity of the brain for external drainage of cerebrospinal fluid (CSF) in those patients with elevated intracranial pressure (ICP), intraventricular hemorrhage, or hydrocephalic shunt infections.

Intraventricular Hemorrhage Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (10)

Loma Linda University Health

Loma Linda, California, 92350, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70808, United States

Location

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

Location

Wright State University/Premier Health

Dayton, Ohio, 45409, United States

Location

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

University of Utah Health

Salt Lake City, Utah, 84123, United States

Location

Virginia Commonwealth University Department of Neurosurgery

Richmond, Virginia, 23298, United States

Location

Related Publications (3)

• Aten Q, Killeffer J, Seaver C, Reier L. Causes, Complications, and Costs Associated with External Ventricular Drainage Catheter Obstruction. World Neurosurg. 2020 Feb;134:501-506. doi: 10.1016/j.wneu.2019.10.105. Epub 2019 Oct 25.

  PMID: 31669535 BACKGROUND

• Fargen KM, Hoh BL, Neal D, O'connor T, Rivera-Zengotita M, Murad GJ. The burden and risk factors of ventriculostomy occlusion in a high-volume cerebrovascular practice: results of an ongoing prospective database. J Neurosurg. 2016 Jun;124(6):1805-12. doi: 10.3171/2015.5.JNS15299. Epub 2015 Oct 30.

  PMID: 26517777 BACKGROUND

• Crites L. Reducing Catheter-Related Complications with New Anti-thrombiogenic PICC. JAVA. 2015:20(4):256.

  BACKGROUND

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ramesh Grandhi, MD

  University of Utah Health

  PRINCIPAL INVESTIGATOR

• Jason Marzuola, MSN

  Integra Life Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: November 9, 2021
• Study Start: September 15, 2021
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)