A prospective, post market, non-interventional observational, open label, singlearm, single center study to validate the clinical safety and performance ofSkanmobile and Skanmobile DR
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 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 Skanmobile and Skanmobile DR 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 device and intended to answer specific questions relating to clinical safety or performance of a device when used in accordance with its approved labeling. Skanmobile is an advanced high frequency mobile diagnostic X-ray system intended for the use in generating radiographic images of human anatomy for general purpose X-ray diagnostic procedures. Skanmobile DR is a variant of Skanmobile with additional feature of flat panel detector, toughbook and imaging software to acquire the image.
Skanmobile and Skanmobile DR are CE certified and available in the market since from 2014 and 2019 respectively.
This is the post market clinical follow up study to proactively collect and review experience gained from the devices placed on the market to ensure the safety and performance of the Skanmobile and Skanmobile DR.
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 authorised 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 Skanmobile and Skanmobile DR found to be appropriate to meet the predefined objectives.
时间窗: Within 14 days after capturing the radiographic image
次要结局
- Collection of feedback from the investigator on the radiographic images collected during the study and usability. This shall meet the predefined objectives to prove the claimed performance of Skanmobile and Skanmobile DR.(Within 20 days after capturing the radiographic image.)