NCT02232009

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not 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 (less than 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.

Conditions

• Image Evaluation

Interventions

Type	Name	Description
DEVICE	3.0 T Neonatal MRI Scanner	Eligible subjects will undergo neonatal MRI scanning procedures.

Timeline

• Start date: 2015-05-07
• Primary completion: 2016-11-30
• Completion: 2016-11-30
• First posted: 2014-09-04
• Last updated: 2019-01-30
• Results posted: 2019-01-30

Locations

1 site across 1 country: United States