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

February 4, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Burbank, California, United States, 91505
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
        • Principal Investigator:
          • Adib Abla, MD
      • 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
        • Principal Investigator:
          • R. Webster Crowley, MD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Not yet recruiting
        • Medstar Health Research Institute
        • Contact:
          • Cynthia Yashinki
        • Principal Investigator:
          • Rocco Armonda, MD
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Terminated
        • Corewell Health
    • Missouri
      • Columbia, Missouri, United States, 65201
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University in St. Louis
        • Principal Investigator:
          • Joshua Osbun, MD
        • Contact:
    • New Jersey
      • Edison, New Jersey, United States, 08820
        • Recruiting
        • JFK university
        • Principal Investigator:
          • Brian Jankowitz, MD
        • Contact:
          • Surekha Patel, MBBS
    • New York
      • Buffalo, New York, United States, 14260
        • Recruiting
        • University at Buffalo
        • Principal Investigator:
          • Adnan Siddiqui, MD
        • Contact:
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Principal Investigator:
          • Tomoyoshi Shigematsu, MD, PhD
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-1350
        • Recruiting
        • University of North Carolina
        • Contact:
          • Patricia Orozco
        • Principal Investigator:
          • Edward Yap, MD
    • 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
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Pennsylvania State University
        • Contact:
          • Olivia Christman
        • Principal Investigator:
          • Ephraim Church, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Terminated
        • University of Pennsylvania
    • South Carolina
      • Greenville, South Carolina, United States, 29601
    • Texas
      • Houston, Texas, United States, 77030
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah
        • Contact:
          • Andrew Grandemange, MBA
        • Principal Investigator:
          • Karol Budohoski, MD
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • University of Washington - Harborview
        • Contact:
        • Principal Investigator:
          • Michael Levitt, MD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Integra LifeSciences Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Icahn School of Medicine at Mount Sinai
Oculus Imaging LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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