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Accuro XV Ultrasound Imaging System for BoneEnhance and Fracture Detection Algorithms
MSK Injury Assessment Imaging System: Feasibility and Data Acquisition for Algorithm Development and Testing
Who can join
Ages 5 and older · All sexes
Full eligibility criteria
Sites are currently on two different protocol Revisions. Inclusion Criteria * Age greater than or equal to 5 years. * The patient is presenting for distal limb injury of the wrist, forearm, ankle, or lower leg. * The patient is scheduled to receive an X-ray that includes a view of the ankle, lower leg, wrist, and/or forearm or any patient that received an X-ray accessible by the study team for the studied anatomy in the past 48 hours. * English and/or Spanish speaking. Exclusion Criteria * An open fracture, grossly open wound, or severe angulation of the limb is present. * Patients for whom the site investigator feels that study participation could prohibit or impair ongoing medical care. * Known allergy to ultrasound couplants.
About the study
The Accuro XV is a cart-based, bedside ultrasound instrument that incorporates new signal processing-based technologies for enhanced bone and soft-tissue imaging.
Patients presenting to the Study Setting (e.g., Emergency Departments, urgent care centers, orthopedic clinics, radiology departments, and other clinical environments with access to standard-of-care (SOC) imaging with a suspected distal extremity injury (wrist, forearm, ankle, or lower leg) who have undergone SOC imaging during their clinical evaluation, will be enrolled for additional extremity imaging with the Accuro XV.
In this feasibility study, we will assess the safety of Accuro XV by review of any adverse events (AEs) and by comparing the comfort level of patients during Accuro XV image capture and standard-of-care imaging. We will retrospectively assess image quality by reviewing all images captured to ensure the image is clear of artifact and other visual imperfections. The de-identified imaging data will then be used for algorithm development and testing. This data will help to verify plans for future study protocols and help to ensure the device is optimized for its clinical use prior to further clinical studies. The results will also be used as an input to RIVANNA's usability and human factors engineering process per IEC 60601-1-6 as recognized by FDA.
The Accuro XV is investigational in this study and is not intended to guide clinical decision-making.
What is being tested
- Accuro XV Ultrasound Imaging System (device)
Sponsor: Rivanna Medical, Inc. · Participants: 25,000 · Started: Jan 29, 2024
Contact the study team
- Joseph Kilroy, PhD · Phone: 804-514-0589
Official record on ClinicalTrials.gov — NCT07853768
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Oct 3, 2026. Each study sets its own eligibility; the study team decides who can join.