Assessing safety and clinical performance of Nanox.ARC device

Not Applicable

• Conditions: Cancer; Musculoskeletal Diseases; Respiratory; Surgery; Orthopaedics

• Registration Number: PACTR202401889439833
• Lead Sponsor: ANOX

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-30
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 200

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified