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

January 29, 2024 updated by: Integra LifeSciences Corporation
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida
        • Principal Investigator:
          • Kunal Vakharia, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
          • Bart Jacher
        • Principal Investigator:
          • R. Webster Crowley, MD
        • Contact:
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Recruiting
        • University of Missouri
        • Principal Investigator:
          • Michael Chicoine, MD
        • Contact:
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University in St. Louis
        • Principal Investigator:
          • Joshua Osbun, MD
        • Contact:
          • Brigette Bahmani
        • Contact:
    • New York
      • Buffalo, New York, United States, 14260
        • Recruiting
        • University at Buffalo
        • Principal Investigator:
          • Adnan Siddiqui, MD
        • Contact:
          • Jennifer Gay
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Principal Investigator:
          • Tomoyoshi Shigematsu, MD, PhD
        • Contact:
          • Colton Smith
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Mark Bain, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma
        • Contact:
        • Principal Investigator:
          • Andrew Bauer, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Terminated
        • University of Pennsylvania
    • South Carolina
      • Greenville, South Carolina, United States, 29601
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • University of Washington - Harborview
        • Principal Investigator:
          • Michael Levitt, MD
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

general population with an acute, spontaneous, primary, supratentorial ICH

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During surgical procedure to evacuate supratentorial intracerebral hemorrhage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integra LifeSciences Corporation

Collaborators

Icahn School of Medicine at Mount Sinai
Oculus Imaging LLC

Investigators

  • Principal Investigator: Christopher Kellner, MD, Icahn School of Medicine at Mount Sinai
  • Study Director: Sigmund Kulessa, Integra LifeSciences Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2020

Primary Completion (Estimated)

October 15, 2028

Study Completion (Estimated)

October 15, 2029

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (Actual)

July 31, 2020

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-MIRROR-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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