Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07455201

Evaluating a Prototype CT Scan for ICH Evacuation

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Intracerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai West

New York, 10019, United States

Location status: Recruiting

Location contact

Christopher Kellner

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Volume of Post-procedure hemorrhage

    Time frame: Immediately post-procedure

    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

Secondary outcomes

  1. Quantitative correlation outcomes of post-procedure hemorrhage

    Time frame: Immediately post-procedure

    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).

  2. Qualitative assessment of the contours of post-procedure hemorrhage

    Time frame: Immediately post-procedure

    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.

  3. Volume of Pre-procedure hemorrhage

    Time frame: Pre-procedure

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Svendsen

CONTACT

[email protected]

212-241-3238

Sydney Edwards

CONTACT

[email protected]

(212) 241-2524

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Siemens Corporation, Corporate Technology

Registry information

Official study title

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

Acronym: ICH-CTP II

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.