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

Description

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

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Intraventricular Hemorrhage
Intervention / Treatment

-

Contacts and Locations

Loma Linda

Loma Linda University Health, Loma Linda, California, United States, 92350

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

Aurora

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Orlando

AdventHealth Orlando, Orlando, Florida, United States, 32803

Baton Rouge

Our Lady of the Lake Regional Medical Center, Baton Rouge, Louisiana, United States, 70808

New York

Icahn School of Medicine at Mt. Sinai, New York, New York, United States, 10029

Dayton

Wright State University/Premier Health, Dayton, Ohio, United States, 45409

Plano

Medical City Plano, Plano, Texas, United States, 75075

San Antonio

University of Texas Health Science Center, San Antonio, Texas, United States, 78229

Salt Lake City

University of Utah Health, Salt Lake City, Utah, United States, 84123

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Integra LifeSciences Corporation,

Ramesh Grandhi, MD, PRINCIPAL_INVESTIGATOR, University of Utah Health

Jason Marzuola, MSN, STUDY_DIRECTOR, Integra Life Sciences

Study Record Dates

2024-12-30