NCT07455201

Evaluating a Prototype CT Scan for ICH Evacuation

Feasibility of the Utilization of Siemens Prototypes in Minimally Invasive ICH Evacuation Treatment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-31
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study