Prospective, post market, non - interventional observational, open label, single arm study to confirm the clinical safety and performance of Skanrays Fixed X-ray Systems
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Collection of feedback which includes user’s assessment of the overall safety and performance of the Skanrays Fixed X-ray Systems
研究概览
简要总结
Skanrays Fixed X-ray Systems are an advanced high frequency type X-ray system designed for superior image quality with a powerful generator and very low X-ray leakage radiation. The models of Skanrays Fixed X-ray Systems includes SKANRAD 400, SKANRAD 500 and SKANRAD 630.
Intended for use in generating radiographic images of human anatomy in all general - purpose X-ray diagnostic procedures. It may be used in radiology departments, pediatrics, orthopedics and clinics.
The system has been designed for indoor usage. It is intended for qualified medical personnel or operators who have been trained in the use of X-ray equipment. Indicated for chest radiography for detectable infections, orthopaedic fractures and dislocations, digestive disorders studies, arthritis, spinal fractures and pain management.
This device is approved by CDSCO, AERB and BIS.
This clinical study is intended to collect feedback from user in the post market phase.
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 female subjects of all age groups.
- •Subjects undergoing radiographic examination based on the advice of a physician.
- •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 study.
排除标准
- •Subjects who have not been advised for radiographic examination by a physician.
- •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 user’s assessment of the overall safety and performance of the Skanrays Fixed X-ray Systems
时间窗: Within 14 days after capturing the radiographic image
次要结局
- Collection of feedback from the radiographer on the safety, performance & usability of the Skanrays Fixed X-ray Systems.