An interventional study of Nanox.ARC Digital Tomosynthesis System in Fracture and Erosion, sponsored by Nano-X Imaging. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Nano-X Imaging · Not applicable, Interventional, and Diagnostic
This is a prospective, single-arm, clinical study evaluating the diagnostic performance of the Nanox.ARC Digital Tomosynthesis (DTS) system in adult patients with suspected or confirmed musculoskeletal (MSK) pathologies presenting to the Emergency Department (ED) or orthopedic outpatient clinic at Meir Medical Center, Israel. The study aims to assess whether DTS provides additional diagnostic information beyond conventional radiography and whether it can reduce the need for advanced imaging (CT/MRI) in MSK patients.
Imaging plays a crucial role in the diagnosis and management of MSK diseases. While conventional radiography is the standard first-line modality, it is limited by superimposition of anatomical structures. Digital Tomosynthesis (DTS) offers high-resolution limited-angle tomography at radiation doses comparable to conventional 2D radiography, with the potential to provide additional clinical information.
The Nanox.ARC is an FDA-cleared and CE-marked stationary DTS system intended for the imaging of anatomical regions of the human body in adult individuals in recumbent positions as an adjunct to conventional radiography. This study will evaluate its performance in MSK imaging in a real-world clinical setting.
Patients with suspected or confirmed MSK pathology who have undergone plain radiography and are referred for or have undergone advanced imaging (CT/MRI) will be enrolled. Each patient will additionally undergo a DTS scan with the Nanox.ARC system.
The study aims to determine:
723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 458 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →This is the only study on the registry with Nano-X Imaging as lead sponsor.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients with suspected or confirmed MSK pathology presenting to the ED or orthopedic clinic who have undergone conventional radiography and are referred to imaging for follow up. All enrolled subjects additionally undergo a single DTS scan with the Nanox.ARC system within 7 days of the initial radiograph.
Device: Nanox.ARC Digital Tomosynthesis System
A single DTS scan of the relevant MSK anatomical region performed using the Nanox.ARC stationary digital tomosynthesis system. The scan consists of multiple sequential low-dose X-ray projections acquired from different angles and reconstructed into tomographic sections. The radiation dose for an extremity scan is approximately 0.003 mSv, significantly lower than a CT scan.
Also known as: DTS; Digital Tomosynthesis; Nanox.ARC
Rate of Cases in Which DTS Provided Additional Diagnostic Information Compared to Conventional Radiography
Proportion of cases in which Nanox.ARC DTS provided additional clinically relevant information compared to conventional 2D radiography, including better depiction and localization of lesions and higher diagnostic confidence, when evaluating adult patients with known or suspected MSK abnormalities.
Time frame: Within 7 days of initial radiograph (single study visit)
Rate of Cases in Which DTS Was Sufficient for Clinical Management Without Requiring Advanced Imaging
Proportion of cases in which Nanox.ARC DTS, in addition to conventional radiography, was sufficient for patient clinical management without requiring CT/MRI or other advanced imaging modalities.
Time frame: Within 7 days of initial radiograph (single study visit)
Plan to share: No
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