CTRI/2018/07/014750进行中（未招募）不适用
Scanning of subjects on in-house MRI systems ≤ 3.0T for the inspection of Image quality and validation of new software enhancements and features.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- MRI System related adjustments
研究概览
简要总结
Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.This MR system enables trained physicians to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin.
Philips Healthtech is a leading provider of MRI systems and solutions.
This study is intended to maintain or enhance the reliability, performance, workflows and clinical acceptance of these MRI solutions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Participant is Healthy Male or Female, aged 18 years or above.
- •Participant has clinically acceptable laboratory ECG Chest X-ray physical health (in the Investigators opinion) and willing to comply with all study requirements.
- •Volunteers’ Participant shall not have any condition that are contra-indicated for undergoing MRI Scanning.
- •Participant is willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the study.
排除标准
- •The participant may not enter the study if ANY of the following apply:
- •Participant with any non-MR compatible implants or metallic foreign bodies, (Example: piercings, metal clips, surgical implants, pacemakers etc.)
- •Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
- •Participants with significant renal, cardiac or hepatic impairment.
- •Participants with scheduled elective surgery or other procedures requiring general anesthesia during the study.
- •Participant who is terminally ill.
- •Participants who have participated in another research study involving an investigational product in the past 12 weeks.
- •Participants with Tattoos, permanent make up, Claustrophobia, anxiety or panic disorders, Epilepsy, and Meniere’s disease.
- •Participants with any other significant disease or disorder, which, in the opinion of the Investigator, may put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
- •Participants with any other condition as deemed unsuitable by the Medical Advisor.
结局指标
主要结局
MRI System related adjustments
时间窗: 6 months
次要结局
- Optimization of image quality and their preset settings(6 months)
研究者
研究点 (1)
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