CerebroFlo™ EVD Catheter for Subarachnoid Hemorrhage

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stanford University, Palo Alto, CASubarachnoid Hemorrhage+1 MoreCerebroFlo™ EVD Catheter - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing how often medical interventions to treat Flushing (redness and swelling) occur during the treatment of two types of hemorrhages.

Eligible Conditions
  • Subarachnoid Hemorrhage
  • Intraventricular Hemorrhage

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Device implantation through to 90-Day follow-up

Device implantation through to 90-Day follow-up
Assessment of Glasgow Coma Score (GCS)
Assessment of Modified Rankin Score (mRS)
Assessment of National Institute of Health Stroke Scale (NIHSS)
Change of hemorrhage volume
Reduction of hemorrhage volume
study device implantation through study device removal
Number of flushing interventions to address occlusions

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Intraventricular Hemorrhage Subjects
1 of 1

Experimental Treatment

109 Total Participants · 1 Treatment Group

Primary Treatment: CerebroFlo™ EVD Catheter · No Placebo Group · N/A

Intraventricular Hemorrhage Subjects
Device
Experimental Group · 1 Intervention: CerebroFlo™ EVD Catheter · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: device implantation through to 90-day follow-up

Who is running the clinical trial?

Integra LifeSciences CorporationLead Sponsor
80 Previous Clinical Trials
9,029 Total Patients Enrolled
1 Trials studying Subarachnoid Hemorrhage
157 Patients Enrolled for Subarachnoid Hemorrhage
Ramesh Grandhi, MDPrincipal InvestigatorUniversity of Utah Health
Jason Marzuola, MSNStudy DirectorIntegra Life Sciences
1 Previous Clinical Trials
500 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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Frequently Asked Questions

Are there any available participation slots for this research endeavor?

"Affirmative. The clinicaltrials.gov registry shows that this particular medical trial, which was first posted on September 15th 2021, is seeking participants for a study involving 109 individuals from 7 different sites." - Anonymous Online Contributor

Unverified Answer

What is the current population of participants in this trial?

"For this research to be successful, 109 qualified participants are required. Prospective patients can enrol in the trial from clinical sites like University of Utah Health (Salt Lake City) and Stanford University (Palo Alto)." - Anonymous Online Contributor

Unverified Answer

How many venues are presently hosting this investigation?

"This medical trial is based out of University of Utah Health in Salt Lake City, Stanford University in Palo Alto and Our Lady of the Lake Regional Medical Center located in Baton Rouge. Additionally, there are 7 other locations associated with this study's operations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.