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NCT07455201NARecruiting

Evaluating a Prototype CT Scan for ICH Evacuation

Icahn School of Medicine at Mount Sinai

Start Date

10/31/2025

Completion Date

12/31/2028

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

DynaCT Multiphase

DEVICE

DynaCT Sine Spin

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Conditions

Intracerebral Hemorrhage

Locations

Mount Sinai West

New York, New York 10019

United States