RECRUITING

The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation

Quick Facts

Study Start:2020-10-23

Study Completion:2029-10-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04494295

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Crystal George

CONTACT

4699684132

crystal.george@integralife.com

Principal Investigator

Sigmund Kulessa

STUDY_DIRECTOR

Integra LifeSciences Corporation

Christopher Kellner, MD

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

University of South Florida

Tampa, Florida, 33606

United States

Rush University Medical Center

Chicago, Illinois, 60612

United States

Corewell Health

Grand Rapids, Michigan, 49503

United States

University of Missouri

Columbia, Missouri, 65201

United States

Washington University in St. Louis

Saint Louis, Missouri, 63110

United States

University at Buffalo

Buffalo, New York, 14260

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

University of Oklahoma

Oklahoma City, Oklahoma, 73104

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Prisma Health - Upstate

Greenville, South Carolina, 29601

United States

University of Washington - Harborview

Seattle, Washington, 98104

United States

Collaborators and Investigators

Sponsor: Integra LifeSciences Corporation

Sigmund Kulessa, STUDY_DIRECTOR, Integra LifeSciences Corporation
Christopher Kellner, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-23

Study Completion Date2029-10-15

Study Record Updates

Study Start Date2020-10-23

Study Completion Date2029-10-15

Terms related to this study

Additional Relevant MeSH Terms

Supratentorial Hemorrhage