Aurora Surgiscope for Brain Bleed

(MIRROR Trial)

Recruiting at 21 trial locations

Overseen By Habib Nacer-Chérif

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Integra LifeSciences Corporation

Disqualifiers: Vascular lesion, Neurological deficit, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool, the Aurora Surgiscope System, to help doctors remove blood clots from the brain in a minimally invasive way. The goal is to evaluate its effectiveness for people with a specific type of brain bleed called a supratentorial hematoma. The trial also examines how quickly patients receive surgery after symptoms begin and whether this timing affects recovery. Suitable candidates for this trial include those who have recently experienced a sudden, large brain bleed and can undergo surgery within 24 hours of symptom onset. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Aurora Surgiscope System is safe for minimally invasive brain surgery?

Research has shown that the Aurora Surgiscope System is used in minimally invasive surgery (MIS). This method allows doctors to see and remove brain blood clots with smaller incisions. Studies have found that MIS, using tools like the Aurora Surgiscope, often leads to better outcomes. Patients typically experience lower death rates and shorter stays in intensive care compared to those undergoing traditional surgery.

One study examined the Aurora Surgiscope's use in removing brain tumors. It found the tool effective and generally safe, with patients not experiencing major negative effects. While individual experiences may vary, current research suggests that the Aurora Surgiscope is usually safe and effective for these surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Aurora Surgiscope System because it offers a minimally invasive way to evacuate intracerebral hematomas, which is a significant advancement over traditional open surgical methods. Unlike standard treatments that often require larger incisions and longer recovery times, the Aurora Surgiscope allows for precise, targeted removal of blood clots with less disruption to surrounding brain tissue. This innovative approach not only aims to reduce surgical risk but also hopes to improve patient outcomes and shorten recovery periods. By streamlining the evacuation process, the Aurora Surgiscope represents a promising new direction in the treatment of intracerebral hemorrhages.

What evidence suggests that the Aurora Surgiscope is effective for minimally invasive removal of hematoma in the brain?

Research has shown that using the Aurora Surgiscope to remove blood clots in the brain through less invasive surgery can be beneficial. In this trial, participants will receive treatment with the Aurora Surgiscope. Studies have found that this method may improve survival rates and reduce intensive care stays compared to medication alone. The Aurora Surgiscope enables surgeons to see and reach the clot more easily, enhancing surgical effectiveness. This technique has also succeeded in other types of brain surgeries. Overall, evidence suggests that the Aurora Surgiscope could improve recovery chances for patients needing blood clot removal. ^{1 2 3 5 6}

Who Is on the Research Team?

Sigmund Kulessa

Principal Investigator

Integra LifeSciences Corporation

Christopher Kellner, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Minimally invasive removal of hematoma using the Aurora® Surgiscope

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the surgical procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aurora Surgiscope System

How Is the Trial Designed?

Group I: AURORA Experimental Treatment 1 Intervention

Aurora® Surgiscope used for MIS evacuation of supratentorial hematoma

Who Is Running the Clinical Trial?

Integra LifeSciences Corporation

Lead Sponsor

Trials

110

Recruited

11,300+

Mojdeh Poul

Integra LifeSciences Corporation

Chief Executive Officer

Bachelor’s and Master’s degrees in Mechanical Engineering from the University of Louisville, MBA from the University of North Carolina at Chapel Hill

Dr. Lisa Egbuonu-Davis

Integra LifeSciences Corporation

Chief Medical Officer since 2023

MD from Harvard Medical School

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

Oculus Imaging LLC

Collaborator

Trials

1

Recruited

500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04494295

The MIRROR Registry: Minimally Invasive IntRaceRebral ... 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8326326/

Minimally Invasive Surgery to Improve Surgical Performance According to the current guidelines, supratentorial hematoma evacuation might be considered as a life-saving measure, and decompression with or ...

3. thejns.org thejns.org/view/journals/j-neurosurg/aop/article-10.3171-2025.3.JNS2565/article-10.3171-2025.3.JNS2565.xml

Minimally invasive surgical evacuation confers a mortality ... MIS evacuation was associated with improved mortality and decreased length of stay in the ICU compared with medical management. Additionally, ...

4. journals.lww.com journals.lww.com/10.1227/ons.0000000000001780

Minimally Invasive Resection of Intracranial Tumors Using... We retrospectively analyzed data for our patients undergoing intracranial tumor resection approaches with the Aurora Surgiscope between July ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04434807

Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage ... A randomized controlled trial of ultra-early, minimally invasive, hematoma evacuation versus standard care within 8 hours of intracerebral hemorrhage.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04434807

Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage ... A randomized controlled trial of ultra-early, minimally invasive, hematoma evacuation versus standard care within 8 hours of intracerebral hemorrhage.