The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation

Description

This registry will study the use of the Aurora® Surgiscope to provide surgical access and visualization in minimally invasive removal of hematoma in the brain. Many methods of hematoma removal are available and will be based on surgeon preference. The impact of patient selection and time to surgery from last known well time will be explored.

Conditions

Supratentorial Hemorrhage

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Study Overview

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Study Details

Study overview

This registry will study the use of the Aurora® Surgiscope to provide surgical access and visualization in minimally invasive removal of hematoma in the brain. Many methods of hematoma removal are available and will be based on surgeon preference. The impact of patient selection and time to surgery from last known well time will be explored.

The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation

The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation

Condition
Supratentorial Hemorrhage
Intervention / Treatment

-

Contacts and Locations

Tampa

University of South Florida, Tampa, Florida, United States, 33606

Chicago

Rush University Medical Center, Chicago, Illinois, United States, 60612

Grand Rapids

Corewell Health, Grand Rapids, Michigan, United States, 49503

Columbia

University of Missouri, Columbia, Missouri, United States, 65201

Saint Louis

Washington University in St. Louis, Saint Louis, Missouri, United States, 63110

Buffalo

University at Buffalo, Buffalo, New York, United States, 14260

New York

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

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Oklahoma City

University of Oklahoma, Oklahoma City, Oklahoma, United States, 73104

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

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

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Integra LifeSciences Corporation,

Sigmund Kulessa, STUDY_DIRECTOR, Integra LifeSciences Corporation

Christopher Kellner, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

2029-10-15