ClinicalTrials.gg
RecruitingNCT04494295MIRRORUpdated Feb 6, 2026

The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation

An observational study in Supratentorial Hemorrhage, sponsored by Integra LifeSciences Corporation. Recruiting at 20 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by Integra LifeSciences Corporation · Observational

From the registry’s dates

  • Started Oct 2020; still recruiting 6 years later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Supratentorial Hemorrhage
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In context

Lead sponsor

Integra LifeSciences Corporation is the lead sponsor of 82 studies on the registry; 5 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 \< 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • AURORA

    Aurora® Surgiscope used for MIS evacuation of supratentorial hematoma

    Device: Aurora Surgiscope System

Interventions

  • DeviceAurora Surgiscope System

    MIS evacuation of hematoma using the Aurora Surgiscope System

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What researchers measure

Primary outcomes

  1. 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

    Time frame: During surgical procedure to evacuate supratentorial intracerebral hemorrhage

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Study locations

16 of 20 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04494295
Collaborators
Icahn School of Medicine at Mount Sinai, Oculus Imaging LLC
Responsible party
Sponsor
First posted
Jul 31, 2020
Start date
Oct 23, 2020
Primary completion
Oct 15, 2028 (estimated)
Completion
Oct 15, 2029 (estimated)
Last update
Feb 6, 2026

Study contacts

Habib Nacer-Chérif
Contact
habib.nacercherif@integralife.com
+33626190029
Sigmund Kulessa
study director · Integra LifeSciences Corporation
Christopher Kellner, MD
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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