Registry for minimally invasive brain hemorrhage evacuation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This registry focuses on the use of the Aurora® Surgiscope to facilitate minimally invasive surgical access and visualization for the removal of hematomas in the brain. It will evaluate various methods of hematoma removal based on surgeon preference and assess the impact of patient selection and timing of surgery from the last known well time. The study aims to gather data on outcomes related to this innovative surgical approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subject Age is \> 18
* Subject with a Head CT that demonstrates an acute, spontaneous, primary, supratentorial ICH of volume \> 20 mL, assessed via standard of care techniques
* Subject Surgery can be initiated within 24 hours of the last known well time or, in patients with wake-up onset, within 24 hours of the time the patient awoke with symptoms.
* Subject has a NIHSS score \> 5
* Subject has a baseline Modified Rankin Scale (mRS) Score ≤ 2
* Subject with a CT Angiography demonstrating no vascular malformation

Exclusion Criteria:

* Subject has an underlying vascular lesion defined as causative source of ICH
* Subject has a profound neurological deficit defined as fixed/dilated pupils or bilateral extensor motor posturing
* Subject has an Infratentorial or brainstem ICH
* Subject has a known life expectancy \< 6 months
* Subject has an uncorrectable coagulopathy
* Subject has a mechanical heart valve
* Subject is pregnant
* Subject participates in another concurrent interventional clinical trial
* Subject who is unable to meet study follow-up requirements

Where it's running

• Providence Health
  Burbank, California, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting
• Rush University Medical Center
  Chicago, Illinois, United States Recruiting
• University of Missouri
  Columbia, Missouri, United States Recruiting
• Washington University in St. Louis
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Christopher Kellner, MD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Habib Nacer-Chérif
• Email: habib.nacercherif@integralife.com
• Phone: +33626190029

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.