Cancer Musculoskeletal Diseases Respiratory Surgery Orthopaedics
Conditions
Interventions
Nanox.ARC
Sponsors
NANOX
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 1.Known or suspected pregnancy. 2.Inability to cooperate during the study and/or to maintain the required position during Nanox.ARC procedures. Nanox.ARC 3.Underwent a change in the medical condition in the same body part since the 2D radiogra
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of cases in which Nanox.ARC DTS provided additional information to conventional 2D radiography when evaluating adult individuals with known or suspected radiographic abnormalities. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of cases in which the Nanox.ARC information was sufficient for subject management without the need for CT/MRI or other advanced imaging studies modalities;Rate of cases in which the DTS increased the level of confidence of the reader in identifying/excluding an abnormality;Duration of physician reading time of Nanox.ARC DTS versus CT/MRI or other advanced imaging modality;Consensus in the majority of the evaluation points between the site readers and IRC members | — |
Countries
Ghana
Contacts
Public ContactYael Schiffenbauer
Head of Clinical
Outcome results
None listed