Recruiting NCT04494295

The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation

— Observational Supratentorial Hemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Aurora Surgiscope System.
Who it may be relevant to: Registry conditions: Supratentorial Hemorrhage. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

Device Aurora Surgiscope System
MIS evacuation of hematoma using the Aurora Surgiscope System

Primary outcome measures

Rate of Surgical Success [Time frame: During surgical procedure to evacuate supratentorial intracerebral hemorrhage]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Case-only

Study locations

United States · 20 centers

Providence Health — Burbank
University of Miami — Miami
University of South Florida — Tampa
Rush University Medical Center — Chicago
MedStar Health Research Institute — Baltimore
Corewell Health — Grand Rapids
University of Missouri — Columbia
Washington University in St. Louis — St Louis
… and 12 more centers

Identifiers

NCT: NCT04494295 · C-MIRROR-001

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗