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| Name | Class |
|---|---|
| Siemens Corporation, Corporate Technology | INDUSTRY |
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The aim of the project is to collect pre-procedural CT scans, intra-procedural post-evacuation scans as well as immediate post-procedural CT scans to evaluate and collect feedback of two Siemens prototypes: 1) perfusion prototype and 2) automatic hemorrhage detection prototype. The assessment of the prototypes, including its features will focus on the feasibility, usefulness as well as the potential clinical value add in minimally invasive ICH treatment.
The aim of the project is to prospectively collect pre-procedural CT scans, intraprocedural scans post-evacuation (7s DynaCT Sine Spin and DynaCT Multiphase) and immediate post-procedural CT scans to evaluate and collect feedback of two Siemens prototypes. The assessment of the prototypes, including its features, will focus on the feasibility, usefulness, and potential clinical value. In addition to the prospective data collection outlined above, already available pre- and post procedural CT data sets as well as pre- and post-evacuation DynaCT Sine Spin data sets will be collected retrospectively (n=5). These data sets were acquired as part of standard of care procedures. The additional data sets will also be included in the evaluation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DynaCT Multiphase scan | Other | All enrolled patients will undergo an extra DynaCT Multiphase scan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DynaCT Multiphase | Device | DynaCT Multiphase device is the perfusion prototype scan. DynaCT Multiphase scans taken intra-operatively will be processed offsite on Siemens' hemorrhage detection and perfusion prototypes. |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of Post-procedure hemorrhage | Quantitative assessment of the comparison of the detected residual hemorrhage on the DynaCT Sine Spin data and the detected residual hematoma on the immediate post-procedural CT | Immediately post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative correlation outcomes of post-procedure hemorrhage | Correlation of the generated perfusion maps (CBV, CBF, MTT, TTP) to other available clinical information. Prespecified variables to be included are; Location of hypoperfusion on FPCT-PI (1-frontal, 2-parietal, 3-temporal, 4-occipital) and presence of residual hypoperfusion on FPCT-PI (1-present, 2-absent). | Immediately post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily Svendsen | Contact | 212-241-3238 | Emily.Svendsen@mountsinai.org | |
| Sydney Edwards | Contact | (212) 241-2524 | Sydney.Edwards@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Kellner | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai West | Recruiting | New York | New York | 10019 | United States |
In order to minimize any privacy risks to the patients participating, IPD data will not be shared.
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| DynaCT Sine Spin | Device | DynaCT Sine Spin scan is the automatic hemorrhage detection prototype. Scans taken intra-operatively will be processed offsite on Siemens' hemorrhage detection and perfusion prototypes. |
|
| Qualitative assessment of the contours of post-procedure hemorrhage | Qualitative assessment of the contours on DynaCT Sine Spin vs postprocedural CT of the hemorrhage detection prototype, using the following scale for evaluation: 1=Clinically usable, 2=Usable with minor edits, 3=Usable with major edits, 4=Redo completely. | Immediately post-procedure |
| Volume of Pre-procedure hemorrhage | Quantitative assessment of the comparison of the detected residual hemorrhage on the DynaCT Sine Spin data and the detected hematoma on the pre-procedural CT | Pre-procedure |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |