NCT02785588

Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit (Firefly Sheffield)

Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 1 Minute – 2 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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. Investigator feedback on scanning conducted under each MR Procedure Document will be documented. Because the device is intended for use in viable neonate and infant populations, clinical data are required that cannot be conducted in any other populations or simulated on non-human models. Clinical images and associated data as well as assessments of image quality, workflow, and usability will be collected. Images, associated image data, and subject data collected in both phases of this study may be used for future engineering development and activities that support MR product development, including Sponsor-authorized scientific and marketing activities. Summary evaluation of safety and performance from Phase 1 and Phase 2 may be used in support of regulatory submission, including filings for European CE mark.

Conditions

• Neonatal Neuroimaging

Interventions

Type	Name	Description
DEVICE	3.0 T Neonatal MRI scanner	eligible subjects will undergo neonatal MRI scan procedure

Timeline

• Start date: 2016-03-22
• Primary completion: 2017-08-20
• Completion: 2018-04-20
• First posted: 2016-05-30
• Last updated: 2019-09-13
• Results posted: 2019-09-13

Locations

1 site across 1 country: United Kingdom