CTRI/2020/12/029799已完成Unknown
A prospective, post market, non-interventional observational, open label, single arm, single center study to validate the clinical safety and performance of microSKAN
Skanray Technologies Pvt Ltd1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年12月16日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Collection of feedback which includes investigator’s assessment of the overall safety and performance of the microSKAN found to be appropriate to meet the predefined objectives.
研究概览
简要总结
Post-market clinical follow-up study is carried out following the CE marking of a medical device and intended to answer specific questions relating to clinical safety or performance of a device when used in accordance with its approved labeling.
microSKAN is an advanced high frequency type X-Ray system designed for superior image quality with powerful 2.8 KW generator and very low leakage radiation. microSKAN is CE certified and available in the market from May 2015.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and non-pregnant female subjects of all age groups.
- •Subjects or legally authorized representatives or guardians on behalf of the subject who are able and willing to provide written informed consent to participate in this clinical investigation.
排除标准
- •Pregnant or suspected to be pregnant based on the opinion of a physician.
结局指标
主要结局
Collection of feedback which includes investigator’s assessment of the overall safety and performance of the microSKAN found to be appropriate to meet the predefined objectives.
时间窗: Within 14 days after capturing the radiographic images.
次要结局
- Collection of feedback from the investigator on the radiographic images collected during the study and on the usability. This shall meet the predefined objectives to prove the claimed performance of microSKAN.(Within 14 days after capturing the radiographic images.)
研究者
研究点 (1)
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