Objective: The primary objective of this multicenter prospective registry is to provide additional safety, technical outcomes and clinical outcomes data for minimally invasive endoscopic surgery (MIES) with Apollo or Artemis for the evacuation of supratentorial brain hemorrhage in adult patients who do not qualify for the concurrent INVEST Feasibility randomized controlled trial at active INVEST centers.
Study Design: This study will be a prospective, non-randomized, multi-center, single arm registry that will enroll up to 50 patients, however may increase to 200 at up to 10 US centers. Patient Population: Adult patients with supratentorial brain hemorrhages (ICH and/or IVH) who do not meet all INCLUSION criteria or who meet one or more EXCLUSION criteria for the INVEST trial, but who will ultimately undergo MIES with Apollo or Artemis at active INVEST centers. Indication: The Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems. The Apollo system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system. In the present study, the researchers propose to investigate the safety and efficacy of this system for the minimally invasive evacuation of brain hemorrhage - both IVH, IVH with ICH and ICH alone - in patients who do not qualify for the INVEST trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
The Apollo system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system.
The Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems.
George Washington University
Washington D.C., District of Columbia, United States
University of Louisville
Louisville, Kentucky, United States
University of Buffalo
Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Number of Participants With Modified Rankin Score (mRS) ≤ 3 or mRS > 3
Clinical Efficacy Endpoint: global disability assessed via the modified Rankin score (mRS). 180-day global disability assessed via the modified Rankin score (mRS), categorized as either mRS ≤ 3 or mRS \> 3
Time frame: 180 days
Number of Participants With Surgical Success Rate
Technical Efficacy Endpoint measured by rate of surgical success. Surgical Success Rate is defined as reduction to \< 15 cc total volume AND \>60% reduction in hemorrhage volume on immediate post-treatment CT scan
Time frame: immediately post-procedure
Number of Participants With Surgical Success Rate Regarding IVH
Technical Efficacy Endpoint measured by rate of surgical success. Surgical Success Rate is defined as Intraventricular hemorrhage (IVH): mGraeb score of \< 5 on day 7 CT scan
Time frame: 7 days post-procedure
Rate of Mortality
Time frame: 30 days post procedure
Modified Rankin Score (mRS) at 30 Days
0: No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
Time frame: 30 days post-procedure
Modified Rankin Score (mRS) at 90 Days
0: No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
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Geisinger Medical Center
Danville, Pennsylvania, United States
Prisma Health
Greenville, South Carolina, United States
University of Washington
Seattle, Washington, United States
Time frame: 90 days post-procedure
Length of Hospital Stay
Time frame: average of 17 days
Number of Participants Requiring VPS
Number of participants requiring Ventriculoperitoneal Shunt (VPS)
Time frame: average of 17 days