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Business decision to focus on other studies. No safety concern.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVH subjects 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 approximately 20 subjects with intracerebral hemorrhages utilizing the Artemis Neuro Evacuation Device in the hyper-acute phase. For the purposes of this registry, the hyper-acute phase as defined by initiation of the MIS procedure no longer than 12 hours from initial NCCT scans and no longer than 18 hours since time patients last known well. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artemis Neuro Evacuation Device | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 hours |
| Safety Endpoint: Rate of mortality at 30 days | Rate of mortality at 30 days | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time of admission at treating facility to discharge (Length of stay) | admission to discharge, a period of up to 30 days | |
| Rate of Ventriculoperitoneal Shunt (VPS) placement within 30 days of procedure | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with spontaneous Intraventricular Hemorrhage not related to underlying vascular abnormality.
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| Name | Affiliation | Role |
|---|---|---|
| Paul Saphier, MD | Atlantic Neuroscience Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantic Neuroscience Institute | Summit | New Jersey | 07901 | United States |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D020300 | Intracranial Hemorrhages |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Procedure and device related SAEs | time of surgery up to 30-day follow-up |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |