Multicentric study for assessing safety and clinical performance and safety of Nanox.ARC in providing additional information to conventional two-dimensional (2D) radiography when evaluating adult individuals with known or suspected radiographic abnormalities

ANOX0 个研究点目标入组 200 人开始时间: 2023年11月30日最近更新: 2024年3月4日

适应症

试验速览

暂无简介。

•1.Age: 18 years old or older (there is no upper limit in age)
•2.Maximal weight: 150 kg
•3.Suspected or confirmed musculoskeletal, pulmonary, or abdominal lesion (such as fractures, erosions, lung diseases, and renal calculi)
•4.An available recent conventional 2D radiograph of the body part where the suspected abnormality(ies) is (are). The conventional 2D radiograph diagnosis must available on the date of enrollment. The following time frame between the radiograph and the Nanox.ARC DTS should be as follows: fracture: 2 weeks, lung infiltration, renal calculi, pleural effusion, and pneumothorax: 1 week, and bone erosions: 1 month.
•5.An available or scheduled advanced imaging study (CT scan or MRI) of the same body part. The advanced imaging diagnosis may have been already performed before the study enrollment day, however the same time frame mentioned above between the Nanox.ARC DTS and the CT or MRI should be followed.
•6.Being cooperative during the Nanox.ARC DTS imaging exam procedure.
•7.The candidate has received all the study details and signed an informed consent form.

•1.Known or suspected pregnancy.
•2.Inability to cooperate during the study and/or to maintain the required position during Nanox.ARC procedures.
•3.Underwent a change in the medical condition in the same body part since the 2D radiogra

发起方

ANOX