Medical Management for Hematoma, Subdural, Chronic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hematoma, Subdural, Chronic+2 More
Medical Management - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is designed to see if a new treatment for chronic subdural hematoma (a buildup of blood on the brain) is safe and effective.

Eligible Conditions
  • Hematoma, Subdural, Chronic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hematoma, Subdural, Chronic

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: within 180-days of intervention

within 180-days of intervention
Treatment failure

Trial Safety

Safety Progress

1 of 3

Other trials for Hematoma, Subdural, Chronic

Trial Design

2 Treatment Groups

No Embolization
1 of 2
Embolization
1 of 2
Active Control
Experimental Treatment

310 Total Participants · 2 Treatment Groups

Primary Treatment: Medical Management · No Placebo Group · N/A

EmbolizationExperimental Group · 3 Interventions: Medical Management, Burr-hole, SQUID · Intervention Types: Other, Procedure, Device
No EmbolizationActiveComparator Group · 2 Interventions: Medical Management, Burr-hole · Intervention Types: Other, Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within 180-days of intervention

Who is running the clinical trial?

AXIOM Real Time MetricsUNKNOWN
2 Previous Clinical Trials
275 Total Patients Enrolled
Embo-Flüssigkeiten A.G.Industry Sponsor
1 Previous Clinical Trials
111 Total Patients Enrolled
Balt ExtrusionIndustry Sponsor
5 Previous Clinical Trials
10,710 Total Patients Enrolled
Balt USALead Sponsor
David Fiorella, MD, PhDPrincipal InvestigatorStony Brook University Medical Center
2 Previous Clinical Trials
1,013 Total Patients Enrolled
Adam Arthur, MD, MPHPrincipal InvestigatorSemmes-Murphy Neurologic and Spine Institute

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are male or female and your age is 30 or older.
You have no symptoms of stroke in the past 12 months.
The subjacent brain is flattened or shifted.
Imaging characteristics indicative of chronicity (≥ 50% of the volume of the collection should be isodense or hypodense to normal cortical gray matter on CT).
You are female and of child-bearing potential
You are willing and able to return to the investigational site for all follow-up visits (e.g., 30-day, 90-day, 180-day and 1-year), as required per protocol.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 27th, 2021

Last Reviewed: October 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.