Supratentorial HemorrhageMIRRORNCT04494295
The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation
An observational study of Supratentorial Hemorrhage, run by Integra LifeSciences Corporation at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supratentorial Hemorrhage
- What is being tested?
- Aurora Surgiscope System
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 20 sitesUnited States
- Study dates
- 23 Oct 2020to 15 Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: general population with an acute, spontaneous, primary, supratentorial ICH
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Subject is pregnant
- Subject participates in another concurrent interventional clinical trial
- Subject who is unable to meet study follow-up requirements
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United States20 sites, 18 recruiting
- Not yet recruiting
MedStar Health Research Institute
Baltimore, Maryland, 21237
Cynthia Yashinki
Rocco Armonda, MD
- Recruiting
University at Buffalo
Buffalo, New York, 14260
Michaela Laskowski, mlaskowski@ubns.com
Adnan Siddiqui, MD
- Recruiting
Providence Health
Burbank, California, 91505
Jeffrey Figueroa, Jeffrey.Figueroa@providence.org
Adi Iyer, MD
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599-1350
Patricia Orozco
Edward Yap, MD
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Rebecca McWilliams, rebecca_mcwilliams@rush.edu
R. Webster Crowley, MD
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Joyce Barmen, barmenj2@ccf.org
Mark Bain, MD
- Recruiting
University of Missouri
Columbia, Missouri, 65201
Brooke Hoffman, hoffmanba@health.missouri.edu
Michael Chicoine, MD
- Recruiting
JFK university
Edison, New Jersey, 08820
Surekha Patel, MBBS
Brian Jankowitz, MD
- Terminated
Corewell Health
Grand Rapids, Michigan, 49503
- Recruiting
Prisma Health - Upstate
Greenville, South Carolina, 29601
Rosie Gaddy, rosie.gaddy@prismahealth.org
Jan Varas Machaj, MD
- Recruiting
Pennsylvania State University
Hershey, Pennsylvania, 17033
Olivia Christman
Ephraim Church, MD
- Not yet recruiting
UT Health
Houston, Texas, 77030
Andrea Gaitan, Andrea.BecerrilGaitan@uth.tmc.edu
Jared Chen, MD
- Recruiting
University of Miami
Miami, Florida, 33136
Adriana Saravia, a.saravia@med.miami.edu
Adib Abla, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Emily Svendsen, emily.svendsen@mountsinai.org
Tomoyoshi Shigematsu, MD, PhD
- Recruiting
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Michael Omini, michael-omini@ouhsc.edu
Andrew Bauer, MD
- Terminated
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Andrew Grandemange, MBA
Karol Budohoski, MD
- Recruiting
University of Washington - Harborview
Seattle, Washington, 98104
Do Lim, dolim@uw.edu
Michael Levitt, MD
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63110
Ramie Heo, heor@wustl.edu
Joshua Osbun, MD
- Recruiting
University of South Florida
Tampa, Florida, 33606
Shardonnai Sims, shardonnaisims@tgh.org
Kunal Vakharia, MD
About this study
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
- Being tested
- Aurora Surgiscope System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aurora Surgiscope SystemDevice
MIS evacuation of hematoma using the Aurora Surgiscope System
| Study group | Role | What they receive |
|---|---|---|
| AURORA | Aurora® Surgiscope used for MIS evacuation of supratentorial hematoma Receives: Device: Aurora Surgiscope System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Surgical Success
Rate of surgical success defined as reduction to < 15 cc total volume of the supratentorial intracerebral hemorrhage on immediate Post-op CT Scan
Measured: During surgical procedure to evacuate supratentorial intracerebral hemorrhage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start23 Oct 2020
- Primary completion15 Oct 2028 (estimated)
- Study completion15 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supratentorial HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Icahn School of Medicine at Mount Sinai, Oculus Imaging LLC
- Responsible party
- Sponsor
- Investigators
- Sigmund Kulessa, Study director, Integra LifeSciences CorporationChristopher Kellner, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494295
- Sponsor's protocol ID
- C-MIRROR-001
- Acronym
- MIRROR
- Status last verified
- Feb 2026
- First submitted
- 28 Jul 2020
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation
- ClinicalTrials.gov ID
- NCT04494295
- Acronym / sponsor ID
- MIRROR / C-MIRROR-001
- Conditions
- Supratentorial Hemorrhage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Icahn School of Medicine at Mount Sinai, Oculus Imaging LLC
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 15 Oct 2028 (estimated)
- Study completion
- 15 Oct 2029 (estimated)
- First posted
- 31 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AURORA | – | Device: Aurora Surgiscope SystemAurora® Surgiscope used for MIS evacuation of supratentorial hematoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- general population with an acute, spontaneous, primary, supratentorial ICH
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aurora Surgiscope SystemMIS evacuation of hematoma using the Aurora Surgiscope System | Device | AURORA |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
Related trials for Supratentorial Hemorrhage
Recruiting
Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage
Intracerebral Haemorrhage, Minimally Invasive Treatment
RecruitingObservational study
Rapid Evacuation and Access of Cerebral Hemorrhage Registry
Intracerebral Hemorrhage
Not yet recruitingPhase 3
Efficacy of Prophylactic Levetiracetam for Improving Functional Outcome in the Acute Phase of Intracerebral Haemorrhage: a Randomised, Double-blind, Placebo-controlled, Phase 3 Trial
Spontaneous Intracerebral Hemorrhage
RecruitingPhase 3
The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial Within ACT-GLOBAL
Intracerebral Hemorrhage, Spontaneous Intracerebral Hemorrhage
Not yet recruiting
Yiqi Huayu Jiedu Therapy for Non-Surgical Supratentorial Hypertensive Intracerebral Hemorrhage
Intracranial Hemorrhage, Hypertensive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sigmund Kulessa study director
Integra LifeSciences Corporation
Christopher Kellner, MD principal investigator
Icahn School of Medicine at Mount Sinai
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Supratentorial Hemorrhage, run by Integra LifeSciences Corporation at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Habib Nacer-Chérif (+33626190029, habib.nacercherif@integralife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Surgical Success (time frame: During surgical procedure to evacuate supratentorial intracerebral hemorrhage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.