Evaluating a Prototype CT Scan for ICH Evacuation (ICH-CTP II)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Device: DynaCT Multiphase; Device: DynaCT Sine Spin

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

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sydney Edwards; Phone Number: (212) 241-2524; Email: Sydney.Edwards@mountsinai.org
• Study Contact Backup: Name: Emily Svendsen; Phone Number: 212-241-3238; Email: emily.svendsen@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Recruiting
      • Mount Sinai West
      • Principal Investigator: Christopher Kellner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: DynaCT Multiphase scan; All enrolled patients will undergo an extra DynaCT Multiphase scan.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Siemens Corporation, Corporate Technology
• Investigators: Principal Investigator: Christopher Kellner, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Minimally invasive hemorrhage evacuation
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Cerebral Hemorrhage
• Other Study ID Numbers: STUDY-25-00145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In order to minimize any privacy risks to the patients participating, IPD data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes