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ACTIVE NOT RECRUITING NA

ProSPective Evaluation of Non-contrast sINe spiN Flat-dEtectoR CT for the Detection of Intracranial hemorrhageS

NCT05458908 · View on ClinicalTrials.gov ↗

Study Summary

Stroke is one of the leading causes of mortality and disability worldwide. Optimization of intra-hospital pathways is as of today one of the most promising research topics in stroke treatment. A potential solution to shorten the time needed for current workflows, and therefore reperfusion, is to do both imaging and subsequent endovascular therapy (EVT) in the angiography suite using non-contrast syngo DynaCT Sine Spin (FDCT) for the exclusion of intracranial hemorrhage and flat detector CT angiography (FDCTA) or digital subtraction angiography for diagnosis of LVO. It is still a matter of debate if FDCT can reliably differentiate between ischemic and hemorrhagic stroke. This study aims to investigate if non-contrast syngo DynaCT Sine Spin imaging is non-inferior to non-contrast MDCT imaging regarding its sensitivity and specificity for the detection of intracranial hemorrhages.

Conditions Studied

Interventions

  • DIAGNOSTIC_TEST Non-contrast cranial MDCT head scan
  • DIAGNOSTIC_TEST Non-contrast syngo DynaCT Sine Spin head scan and application software

Study Locations (14)

Other

  • HUS — Helsinki
  • CHRU de Tours — Tours
  • Hospital Vall d'Hebron — Barcelona
  • University Hospital Basel — Basel
  • Inselspital Bern — Bern
  • Kantonsspital Luzern — Lucerne

Illinois

  • AdvocateAurora Health — Chicago
  • Nortshore University Health System — Chicago

New York

  • New York University Langone Health — New York
  • Mount Sinai Health System — New York

Colorado

  • Swedish Medical Center — Denver

Pennsylvania

  • Hospital of the University of Pennsylvania — Philadelphia

Tennessee

  • Semmes Murphy Clinic — Memphis

Virginia

  • University of Virginia Health System — Charlottesville

Trial Details

FieldValue
Enrollment Target 252 participants
Start Date 2022-10-25
Est. Completion 2026-03-15
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05458908

The ClinicalTrials.gov registry entry for NCT05458908 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 252 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospital, Basel, Switzerland, which has 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Stroke appearing as the primary indexed condition, and to 2 interventions — of which Non-contrast cranial MDCT head scan is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05458908 reports 14 study locations spanning 7 distinct geographic areas — top geographies include Other, Illinois, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05458908 about?

NCT05458908 is a clinical study titled "ProSPective Evaluation of Non-contrast sINe spiN Flat-dEtectoR CT for the Detection of Intracranial hemorrhageS". Stroke is one of the leading causes of mortality and disability worldwide. Optimization of intra-hospital pathways is as of today one of the most promising research topics in stroke treatment. A potential solution to shorten the time needed for current workflows, and therefore reperfusion, is to do ...

What is the current status of trial NCT05458908?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 252 participants. The study started on 2022-10-25. Estimated completion is 2026-03-15.

What conditions does trial NCT05458908 study?

This clinical trial studies the following conditions: Stroke. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05458908?

The interventions under investigation include: Non-contrast cranial MDCT head scan (DIAGNOSTIC_TEST), Non-contrast syngo DynaCT Sine Spin head scan and application software (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05458908?

This trial is sponsored by University Hospital, Basel, Switzerland, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05458908 being conducted?

This trial has 14 study locations across Colorado, Illinois, New York, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial