Evaluating a Prototype CT Scan for ICH Evacuation

NCT07455201 | Recruiting FDA Device

• 1 other identifier: STUDY-25-00145
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracerebral Hemorrhage

Keywords

Minimally invasive hemorrhage evacuation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quantitative correlation outcomes of post-procedure hemorrhage

  Immediately post-procedure

• Qualitative assessment of the contours of post-procedure hemorrhage

  Immediately post-procedure

• Volume of Pre-procedure hemorrhage

  Pre-procedure

Study Arms (1)

DynaCT Multiphase scan

OTHER

All enrolled patients will undergo an extra DynaCT Multiphase scan.

Device: DynaCT Multiphase; Device: DynaCT Sine Spin

Interventions

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 Multiphase scan

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.

DynaCT Multiphase scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥ 18 years old
• Patient is planned to undergo minimally invasive hemorrhage evacuation at Mount Sinai West Hospital

You may not qualify if:

• Patient is \< 18 years old
• Patient is not planned to undergo minimally invasive hemorrhage evacuation at Mount Sinai West Hospital

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Siemens Corporation, Corporate Technology: collaborator

Study Sites (1)

Mount Sinai West

New York, New York, 10019, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Christopher Kellner

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Svendsen

CONTACT

212-241-3238; Emily.Svendsen@mountsinai.org

Sydney Edwards

CONTACT

(212) 241-2524; Sydney.Edwards@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: March 6, 2026
• Study Start: October 31, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)