Evaluating a Prototype CT Scan for ICH Evacuation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DynaCT Multiphase, DynaCT Sine Spin.
- Who it may be relevant to
- Registry conditions: Intracerebral Hemorrhage. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility of the Utilization of Siemens Prototypes in Minimally Invasive ICH Evacuation Treatment
Overview
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.
Detailed description
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
Interventions
- Device DynaCT Multiphase
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. - Device DynaCT Sine Spin
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.
Primary outcome measures
- Volume of Post-procedure hemorrhage [Time frame: Immediately post-procedure]
Secondary outcome measures (3)
- Quantitative correlation outcomes of post-procedure hemorrhage [Time frame: Immediately post-procedure]
- Qualitative assessment of the contours of post-procedure hemorrhage [Time frame: Immediately post-procedure]
- Volume of Pre-procedure hemorrhage [Time frame: Pre-procedure]
Eligibility criteria
Inclusion criteria
- Patient ≥ 18 years old
- Patient is planned to undergo minimally invasive hemorrhage evacuation at Mount Sinai West Hospital
Exclusion criteria
- Patient is < 18 years old
- Patient is not planned to undergo minimally invasive hemorrhage evacuation at Mount Sinai West Hospital
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mount Sinai West — New York
Identifiers
NCT: NCT07455201 · STUDY-25-00145