Image Evaluation Clinical Trial
Official title:
Development of MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit
This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for imaging viable neonate and infant populations. This MR system has a smaller size and design features that may make it more feasible to locate the system in close proximity to care areas for neonates (birth - 1 month) and infants (less than 1 month to two years), such as clinical neonatal intensive care units (NICUs) and other infant and neonatal care departments.
This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for
imaging viable neonate and infant populations. This MR system has a smaller size and design
features that may make it more feasible to locate the system in close proximity to care areas
for neonates (birth - 1 month) and infants (>1 month to two years), such as clinical neonatal
intensive care units (NICUs) and other infant and neonatal care departments.
This is a two-phase prospective clinical study evaluating the performance and safety of the
investigational MRI device for neonates and infants, including:
- Phase 1 - Initial feasibility assessment and optimization study (Phase 1) which may
include hardware and software modifications. These studies are guided by a series of MR
scanning procedures defined in sequential Sponsor-provided MR Procedure Documents
- Phase 2 - Controlled image and data collection study based on Phase 1 results, in which
optimized scan procedure(s) according to MR Procedure Document(s) will be provided at
the start of Phase 2 scanning and a fixed hardware and integrated software configuration
will be applied for all subjects.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06213870 -
Screening of Endovascular Thrombectomy With MRI in Acute Ischemic Stroke
|