Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Number of Participants Who Experienced an Adverse Event in Phase 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently admitted for treatment or observation at the investigational site at the time of enrolment;
- •weight range less than 5.0 kg (<5.0 kg ) and more than 0.5 kg (>0.5 kg );
- •Viable neonates (birth to 1 month of age) or infants (>1 month to two years of age);
- •Able to safely undergo an MRI scan, as determined by medically qualified personnel;
- •Have parent(s), guardian(s), or legally authorized representative(s) willing and able to provide written informed consent for the subject's participation;
- •Are of appropriate size and shape to fit into the bore of the magnet, inclusive of all monitoring equipment, if any, necessary for the subject's routine clinical care based on standard of care measurement methods, in accordance with site policies :
- •Maximum width (shoulder-to-shoulder measurement) less than eighteen (18 cm).
- •Maximum length (head-to-foot measurement) less than sixty (60) cm.
排除标准
- •Have parent(s), guardian(s), or legally authorized representative(s) that require that they accompany the subject into the MR environment that have contraindications to the MR environment or would otherwise be put at undue risk or discomfort, as determined by medically qualified personnel;
- •Have any ferrous or electrical items or non-removable medical devices that are not compatible with MR scanning (including devices labelled as MR Unsafe, MR conditional for which the scanning conditions are not met, or without MR safety labelling that does not satisfy site MR safety requirements) that may pose hazards in the MR scanning or MR environment, in the opinion of the Principal Investigator or medically qualified personnel in accordance with the site's MR Safety policy;
- •Have any contraindications or could otherwise be expected to experience detrimental effects to safety, well-being, or medical care, as determined by the Principal Investigator or medically qualified personnel in accordance with the site's MR Safety policy;
- •Require any scheduled standard of care procedures that are expected to be adversely impacted by participation in this study, in the opinion of the principal investigator or medically qualified personnel; and
- •Have been previously enrolled AND undergone any study procedures under the current study protocol (i.e. the same subject cannot undergo study procedures, including swaddling and/or MR scanning, more than once).
结局指标
主要结局
Number of Participants Who Experienced an Adverse Event in Phase 2
时间窗: 1 Day
Safety will be assessed based on the number of Adverse Events in Phase 2.
Number of Participants Who Experienced an Adverse Event in Phase 1
时间窗: 1 Day
Safety will be assessed based on the number of Adverse Events in Phase 1.
Image Diagnostic Quality for Phase 1
时间窗: 1 Day
Number of subject whose images were rated as Evaluable.
Image Diagnostic Quality for Phase 2
时间窗: 1 Day
Number of subject whose images were rated as Evaluable.
次要结局
- Overall Experience With the Neonatal MR Scanner Device Summary(1 Day)
- Technical Issues and Malfunctions(1 Day)
- Per Subject Workflow and Transport Information(1 Day)
- Bi-polar Product Description Scale(1 Day)
- Subject Change in Temperature(1 Day)
- Summary of Image Quality and Assessments for Phase 2(1 Day)
- Summary of Image Quality and Assessment for Phase 1(1 Day)