Intracerebral HemorrhageICH-CTP IINCT07455201
Evaluating a Prototype CT Scan for ICH Evacuation
A study testing DynaCT Multiphase and DynaCT Sine Spin in people with Intracerebral Hemorrhage, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- DynaCT Multiphase and DynaCT Sine Spin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥ 18 years old
- Patient is planned to undergo minimally invasive hemorrhage evacuation at Mount Sinai West Hospital
Who cannot join
- Patient is < 18 years old
- Patient is not planned to undergo minimally invasive hemorrhage evacuation at Mount Sinai West Hospital
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai West
New York, New York, 10019
Christopher Kellner
About this study
Official title: 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.
Read the 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
- Being tested
- DynaCT Multiphase, DynaCT Sine Spin
- Keywords
- Minimally invasive hemorrhage evacuation
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DynaCT MultiphaseDevice
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 SpinDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| DynaCT Multiphase scan | Other | All enrolled patients will undergo an extra DynaCT Multiphase scan. Receives: Device: DynaCT Multiphase; Device: DynaCT Sine Spin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately post-procedure
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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
Measured: Pre-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start31 Oct 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Responsible party
- Principal investigator, Christopher P Kellner, Icahn School of Medicine at Mount Sinai
- Investigators
- Christopher Kellner, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455201
- Sponsor's protocol ID
- STUDY-25-00145
- Acronym
- ICH-CTP II
- Status last verified
- May 2026
- First submitted
- 27 Jan 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: In order to minimize any privacy risks to the patients participating, IPD data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Utilization of Siemens Prototypes in Minimally Invasive ICH Evacuation Treatment
- ClinicalTrials.gov ID
- NCT07455201
- Acronym / sponsor ID
- ICH-CTP II / STUDY-25-00145
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Minimally invasive hemorrhage evacuation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DynaCT Multiphase scan | Other | Device: DynaCT Multiphase, Device: DynaCT Sine SpinAll enrolled patients will undergo an extra DynaCT Multiphase scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient ≥ 18 years old
- Patient is planned to undergo minimally invasive hemorrhage evacuation at Mount Sinai West Hospital
Key exclusion criteria (2 listed)
- Patient is < 18 years old
- Patient is not planned to undergo minimally invasive hemorrhage evacuation at Mount Sinai West Hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DynaCT MultiphaseDynaCT 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 Multiphase scan |
| DynaCT Sine SpinDynaCT Sine Spin scan is the automatic hemorrhage detection prototype. Scans taken intra-operatively will be processed offsite on Siemens' hemorrhage detection and perfusion prototypes. | Device | DynaCT Multiphase scan |
Primary outcome
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
3 secondary outcomes
Quantitative correlation outcomes of post-procedure hemorrhage
Time frame: Immediately post-procedure
Qualitative assessment of the contours of post-procedure hemorrhage
Time frame: Immediately post-procedure
Volume of Pre-procedure hemorrhage
Time frame: Pre-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. In order to minimize any privacy risks to the patients participating, IPD data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Kellner principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DynaCT Multiphase and DynaCT Sine Spin in people with Intracerebral Hemorrhage, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Svendsen (212-241-3238, Emily.Svendsen@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of Post-procedure hemorrhage (time frame: Immediately post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.