The purpose of this prospective, single center, single arm registry is to assess technical feasibility, peri-procedural complications, post-procedure imaging outcomes, and 30-day safety outcomes in subjects with intraventricular hemorrhages utilizing the Artemis Neuro Evacuation Device in the hyper-acute phase.
The purpose of this prospective, single center, single arm registry is to assess technical feasibility, peri-procedural complications, post-procedure imaging outcomes, and 30-day safety outcomes in subjects with intracerebral hemorrhages utilizing the Artemis Neuro Evacuation Device in the hyper-acute phase. 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 enrollment period will end once 20 evaluable subjects have been enrolled in the registry. Each subject will be in the registry for approximately 1 month.
Study Type
OBSERVATIONAL
Enrollment
4
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 Artemis Device will be evaluated by descriptive statistics in this registry to assess its efficiency and reliability in minimally invasive, mechanical evacuation of hematoma in patients with intracranial hemorrhage under direct visualization and control using a neuroendoscope.
Atlantic Neuroscience Institute
Summit, New Jersey, United States
Efficacy Endpoint: Post-Procedural Hemorrhage reduction of ≥ 85% in hemorrhage volume assessed by CT at 24 hours
Post-Procedural Hemorrhage reduction of ≥ 85% in hemorrhage volume assessed by CT at 24 hours
Time frame: 24 hours
Safety Endpoint: Rate of mortality at 30 days
Rate of mortality at 30 days
Time frame: 30 days
Time of admission at treating facility to discharge (Length of stay)
Time frame: admission to discharge, a period of up to 30 days
Rate of Ventriculoperitoneal Shunt (VPS) placement within 30 days of procedure
Time frame: 30 days
Procedure and device related SAEs
Time frame: time of surgery up to 30-day follow-up
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