Feasibility Assessment of the Wellumio 'Axana' 0.1T Portable Magnetic Resonance Imaging Device The 'Portable MRI Study'
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants With Device-Related Adverse Events
研究概览
简要总结
To assess the safety and feasibility of the Wellumio 'Axana' device in the hospital setting with healthy controls and patients.
详细描述
This study aims to identify if the Wellumio 'Axana' device, a portable 0.1T MRI, is feasible, safe and reliable for use in the hospital setting.
Primary Objective
- To assess the safety (adverse events) and feasibility (ability to acquire a scan, in a timely manner without technical fault) of the Wellumio 'Axana' device in the hospital setting with healthy controls and patients.
Secondary Objective
- Assess usability of the Axana device.
- Acquire physiological data from healthy controls and hospital patients with the 'Axana' device, and hospital MRI scanners.
- Investigate the repeatability and reproducibility of scans acquired with the Axana device within and between participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Participants:
- •Adults aged 18 years or older.
- •Able to undergo an in-hospital MRI scan.
- •Able to provide informed consent.
- •Head size considered suitable for scanning with the Wellumio Axana brain scanner.
- •Hospital Patients:
- •Adults aged 18 years or older.
- •Presenting to hospital with an acute neurological deficit suspected to be stroke within 24 hours of symptom onset.
- •Clinical and radiological diagnosis of stroke, including ischemic stroke, haemorrhagic stroke, or subarachnoid haemorrhage.
- •Able to undergo an in-hospital MRI scan.
- •Up to 72 hours post-acute stroke.
- •Able to provide written informed consent or, where this is not possible, informed consent provided by a legally authorised representative.
- •Head size considered suitable for scanning with the Wellumio Axana brain scanner.
排除标准
- •Pregnant or breastfeeding.
- •Contraindication to neuroimaging, including any condition that prohibits MRI.
- •Presence of an implanted electro-stimulating device in the head or neck.
- •Presence of a large metallic craniofacial implant, such as a bone fixation plate or mesh. Small metallic objects, such as aneurysm coils, are acceptable.
- •Presence of an intracranial pressure monitor or another similar sensor that may compromise placement of the investigational device.
- •Inability to wear the investigational device, including because of scalp skin lesions or previous intracranial surgery.
- •Unable to lie still for the duration of the scan.
- •Any other condition or symptom that, in the investigator's judgement, prevents participation in the study.
- •Unable to provide informed consent and, where applicable, consent cannot be obtained from a legally authorised representative.
- •Healthy Participants:
- •History of a neurological condition, including brain tumour, previous stroke, or neurological trauma.
- •Post-study MRI findings indicating a brain condition associated with structural changes.
研究组 & 干预措施
Control Arm: 10 healthy controls
Healthy controls with no brain structural changes will be scanned up to 3 times in one session with the 'Axana' device, and have a concurrent hospital brain MRI scan.The hospital MRI performed should consist of a minimum of a T2, FLAIR, ADC, DWI and GRE.
干预措施: Axana Scan and MRI (Diagnostic Test)
Test Arm: 50 stroke subjects
Patients admitted to hospital with a stroke will be scanned with the 'Axana' device during their hospital stay. Patients will be booked in for a hospital MRI scan as per standard in-hospital processes. On the day of the MRI scan, patients will have two 'Axana' device scans (Scan 1& 2). These scans must all happen on the same day and no strict order or scans are required. There must be no more than 6 hours between the hospital MRI and 'Axana' scans. The hospital MRI performed should consist of a minimum of a T2, FLAIR, ADC, DWI and GRE.
干预措施: Axana Scan and MRI (Diagnostic Test)
结局指标
主要结局
Number of Participants With Device-Related Adverse Events
时间窗: During the Axana scan and immediately following completion of the scan
Number of participants experiencing one or more adverse events considered related to the Axana device or scanning procedure
Proportion of Axana Scan Attempts Successfully Completed Without Technical Failure
时间窗: During each Axana scanning session
Proportion of attempted Axana scans successfully completed without a technical fault preventing scan acquisition
Time Required to Complete an Axana Scan
时间窗: During each Axana scanning session
Elapsed time, measured in minutes, required to complete an Axana scan
次要结局
- User-Reported Usability of the Axana Device(Immediately after each Axana scanning session)
- Agreement Between Axana and Hospital MRI Findings(Axana and hospital MRI examinations performed on the same day, with no more than 6 hours between examinations)
- Within-Participant Repeatability of Axana Scans(Day 1 During the same Axana scanning session)