Registry for minimally invasive brain hemorrhage evacuation
The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation
Integra LifeSciences Corporation · NCT04494295
This study looks at using a special tool to help doctors remove blood clots from the brain in a less invasive way and see how different choices affect patient recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Integra LifeSciences Corporation (industry) |
| Locations | 20 sites (Burbank, California and 19 other locations) |
| Trial ID | NCT04494295 on ClinicalTrials.gov |
What this trial studies
This registry focuses on the use of the Aurora® Surgiscope to facilitate minimally invasive surgical access and visualization for the removal of hematomas in the brain. It will evaluate various methods of hematoma removal based on surgeon preference and assess the impact of patient selection and timing of surgery from the last known well time. The study aims to gather data on outcomes related to this innovative surgical approach.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with acute, spontaneous, primary supratentorial intracerebral hemorrhage greater than 20 mL and who can undergo surgery within 24 hours of symptom onset.
Not a fit: Patients with underlying vascular lesions, profound neurological deficits, or those with infratentorial hemorrhages may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved surgical outcomes and recovery for patients with acute supratentorial hemorrhages.
How similar studies have performed: While this approach is innovative, similar minimally invasive techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Burbank, California and 19 other locations
- Providence Health — Burbank, California, United States (RECRUITING)
- University of Miami — Miami, Florida, United States (RECRUITING)
- University of South Florida — Tampa, Florida, United States (RECRUITING)
- Rush University Medical Center — Chicago, Illinois, United States (RECRUITING)
- MedStar Health Research Institute — Baltimore, Maryland, United States (NOT_YET_RECRUITING)
- Corewell Health — Grand Rapids, Michigan, United States (TERMINATED)
- University of Missouri — Columbia, Missouri, United States (RECRUITING)
- Washington University in St. Louis — St Louis, Missouri, United States (RECRUITING)
- JFK university — Edison, New Jersey, United States (RECRUITING)
- University at Buffalo — Buffalo, New York, United States (RECRUITING)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
- University of North Carolina — Chapel Hill, North Carolina, United States (RECRUITING)
- Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
- University of Oklahoma — Oklahoma City, Oklahoma, United States (RECRUITING)
- Pennsylvania State University — Hershey, Pennsylvania, United States (RECRUITING)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (TERMINATED)
- Prisma Health - Upstate — Greenville, South Carolina, United States (RECRUITING)
- UT Health — Houston, Texas, United States (NOT_YET_RECRUITING)
- University of Utah — Salt Lake City, Utah, United States (RECRUITING)
- University of Washington - Harborview — Seattle, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: Christopher Kellner, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Habib Nacer-Chérif
- Email: habib.nacercherif@integralife.com
- Phone: +33626190029
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Supratentorial Hemorrhage