NICU MR Scanner - Version 1
Research type
Research Study
Full title
Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit
IRAS ID
159740
Contact name
Paul D Griffiths
Contact email
Sponsor organisation
GE Medical Systems, LLC
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Brief Description of Study Purpose:
This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for imaging 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 and infants, such as clinical neonatal intensive care units (NICUs) and other infant and neonatal care departments.
This is a two-phase prospective clinical study, including:
• Phase 1 - Initial adaptive 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. Images and associated data from Phase 2 are intended for use for regulatory submissions and certifications.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0056
Date of REC Opinion
1 May 2015
REC opinion
Further Information Favourable Opinion