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The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation (MIRROR)

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ClinicalTrials.gov Identifier: NCT04494295
Recruitment Status : Recruiting
First Posted : July 31, 2020
Last Update Posted : June 28, 2023
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
Oculus Imaging LLC
Information provided by (Responsible Party):
Integra LifeSciences Corporation

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Supratentorial Hemorrhage Device: Aurora Surgiscope System

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation
Actual Study Start Date : October 23, 2020
Estimated Primary Completion Date : October 15, 2028
Estimated Study Completion Date : October 15, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Groups and Cohorts
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Group/Cohort Intervention/treatment
AURORA
Aurora® Surgiscope used for MIS evacuation of supratentorial hematoma
 Device: Aurora Surgiscope System
MIS evacuation of hematoma using the Aurora Surgiscope System


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Surgical Success [ Time Frame: During surgical procedure to evacuate supratentorial intracerebral hemorrhage ]
    Rate of surgical success defined as reduction to < 15 cc total volume of the supratentorial intracerebral hemorrhage on immediate Post-op CT Scan


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
general population with an acute, spontaneous, primary, supratentorial ICH
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04494295


Contacts
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Contact: Crystal George 4699684132 crystal.george@integralife.com

Locations
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United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Kassandra Jones       kassandraj@usf.edu   
Principal Investigator: Kunal Vakharia, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Bart Jacher         
Principal Investigator: R. Webster Crowley, MD         
United States, Michigan
Spectrum Health Not yet recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Beenish Sultan       beenish.ismail@spectrumhealth.org   
Principal Investigator: Justin Singer, MD         
United States, Missouri
University of Missouri Not yet recruiting
Columbia, Missouri, United States, 65201
Contact: Jennifer Randolph       randolphjl@health.missouri.edu   
Principal Investigator: Michael Chicoine, MD         
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Brigette Vaughn         
Principal Investigator: Joshua Osbun, MD         
United States, New York
University at Buffalo Recruiting
Buffalo, New York, United States, 14260
Contact: Jennifer Gay         
Principal Investigator: Adnan Siddiqui, MD         
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Nicole Smeck         
Principal Investigator: Tomoyoshi Shigematsu, MD, PhD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Joyce Barmen       barmenj2@ccf.org   
Principal Investigator: Mark Bain, MD         
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Michael Omini       michael-omini@ouhsc.edu   
Principal Investigator: Andrew Bauer, MD         
United States, Pennsylvania
University of Pennsylvania Terminated
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Prisma Health - Upstate Recruiting
Greenville, South Carolina, United States, 29601
Contact: Rosie Gaddy         
Principal Investigator: Raymond Turner, MD         
United States, Washington
University of Washington - Harborview Recruiting
Seattle, Washington, United States, 98104
Contact: Jade Keen         
Principal Investigator: Michael Levitt, MD         
Sponsors and Collaborators
Integra LifeSciences Corporation
Icahn School of Medicine at Mount Sinai
Oculus Imaging LLC
Investigators
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Study Director: Jason Marzuola, MSN Integra LifeSciences Corporation
Principal Investigator: Christopher Kellner, MD Icahn School of Medicine at Mount Sinai
More Information
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Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT04494295    
Other Study ID Numbers: C-MIRROR-001
First Posted: July 31, 2020    Key Record Dates
Last Update Posted: June 28, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases