See if a new tomosynthesis imaging tool helps diagnose MSK issues in ED and clinic

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm study evaluating the diagnostic performance of the Nanox.ARC Digital Tomosynthesis system in adults with suspected or confirmed musculoskeletal pathology presenting to the emergency department or orthopedic clinics. Participants undergo a DTS scan in addition to standard radiography, with the goal of seeing if DTS provides additional clinically relevant information and could lower the future need for CT or MRI. The system is FDA-cleared and CE-marked as an adjunct to radiography, and the study will be conducted in real-world clinical settings at Meir Medical Center, Israel. Outcomes focus on incremental diagnostic information and potential reductions in radiation exposure and healthcare costs. Eligible participants are adults who have had a plain radiograph within 7 days and are undergoing or scheduled for further imaging.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female patients aged 18 years or older.
2. Ability and willingness to read, understand, and sign the Informed Consent Form (ICF).
3. Clinical status: has undergone a conventional radiograph with or without advanced imaging (CT/MRI) within the past 7 days for a suspected or confirmed MSK pathology; OR is referred to undergo advanced imaging (CT/MRI) or an additional radiograph within the same 7-day timeframe, in the presence of an available radiograph.
4. Negative pregnancy test (for women under the age of 50).

Exclusion Criteria:

1. Cases in which a delay caused by participation in the study could negatively impact the patient's clinical condition or pose a risk to their health or life.
2. Pregnant or breastfeeding women.
3. Body weight exceeding 150 kg.
4. Inability to cooperate with the study procedures or to maintain the required position during the DTS scan.

Where it's running

• Meir Medical Center5
  Kfar Saba, Israel Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.