NCT04494295

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
42mo left

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Oct 2020Oct 2029

First Submitted

Initial submission to the registry

July 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

October 23, 2020

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2029

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

8 years

First QC Date

July 28, 2020

Last Update Submit

February 4, 2026

Conditions

Supratentorial Hemorrhage

Outcome Measures

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

    During surgical procedure to evacuate supratentorial intracerebral hemorrhage

Study Arms (1)

AURORA

Aurora® Surgiscope used for MIS evacuation of supratentorial hematoma

Device: Aurora Surgiscope System

Interventions

Aurora Surgiscope SystemDEVICE

MIS evacuation of hematoma using the Aurora Surgiscope System

AURORA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Providence Health

Burbank, California, 91505, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MedStar Health Research Institute

Baltimore, Maryland, 21237, United States

NOT YET RECRUITING

Corewell Health

Grand Rapids, Michigan, 49503, United States

TERMINATED

University of Missouri

Columbia, Missouri, 65201, United States

RECRUITING

Washington University in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

JFK university

Edison, New Jersey, 08820, United States

RECRUITING

University at Buffalo

Buffalo, New York, 14260, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27599-1350, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Pennsylvania State University

Hershey, Pennsylvania, 17033, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

TERMINATED

Prisma Health - Upstate

Greenville, South Carolina, 29601, United States

RECRUITING

UT Health

Houston, Texas, 77030, United States

NOT YET RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

University of Washington - Harborview

Seattle, Washington, 98104, United States

RECRUITING

Study Officials

  • Sigmund Kulessa

    Integra LifeSciences Corporation

    STUDY DIRECTOR

  • Christopher Kellner, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Habib Nacer-Chérif

CONTACT

+33626190029habib.nacercherif@integralife.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2020

First Posted

July 31, 2020

Study Start

October 23, 2020

Primary Completion (Estimated)

October 15, 2028

Study Completion (Estimated)

October 15, 2029

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

US(20)