Accuro XV ultrasound imaging for bone and fracture detection
Official title: MSK Injury Assessment Imaging System: Feasibility and Data Acquisition for Algorithm Development and Testing
Run by Rivanna Medical, Inc. · NCT07853768 · Data updated 2026-11-12
This study tests the Accuro XV ultrasound system to see if it can safely and comfortably provide clearer images of distal arm and leg injuries compared with standard imaging.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 5 Years and up |
| Sex | All |
| Enrollment | 25000 (estimated) |
| Sponsor | Rivanna Medical, Inc. Industry-sponsored |
| Drugs / interventions | cart |
| Locations | 10 sites (San Francisco, California and 9 other locations) |
| Status | Recruiting |
| Started | January 29, 2024 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT07853768 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Patients aged 5 years and older with suspected distal limb injuries (wrist, forearm, ankle, or lower leg) who are scheduled for X-rays and can be evaluated in English or Spanish.
✕Probably not a fit
Patients with open fractures, severe wounds, or conditions where study participation could interfere with standard care may not benefit from this imaging approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This feasibility study evaluates the Accuro XV bedside ultrasound device for imaging distal extremity injuries (wrist, forearm, ankle, lower leg) in clinical settings where standard imaging is already used. It will review safety by tracking adverse events and assess patient comfort during image capture compared with standard imaging. Researchers will also retrospectively review captured images to check for artifacts and overall image quality. The study will be conducted at multiple centers and involves patients who are already undergoing X-rays for suspected distal limb injuries. Enrollment includes English- and Spanish-speaking participants aged 5 years and older.
Why it matters
Potential benefit: If successful, the Accuro XV could provide clearer, safer imaging at the bedside and potentially streamline assessment of distal extremity injuries.
How similar studies have gone: Previous studies of advanced ultrasound in musculoskeletal imaging have shown promise for improved visualization, but this exact device and protocol are being tested in a feasibility study.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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The University of California San Francisco
San Francisco, California, United States Recruiting -
The University of Colorado Denver
Denver, Colorado, United States Recruiting -
Yale University
New Haven, Connecticut, United States Recruiting -
Rush University Medical Center
Chicago, Illinois, United States Recruiting -
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States Recruiting -
The University of Texas Southwestern
Dallas, Texas, United States Recruiting
Show 4 more locations
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Texas Tech University Health Sciences Center
El Paso, Texas, United States Recruiting -
The University of Utah
Salt Lake City, Utah, United States Recruiting -
The University of Virginia
Charlottesville, Virginia, United States Recruiting -
Virginia Commonwealth University
Richmond, Virginia, United States Recruiting
Study contacts
- Study coordinator: Delphine Le Roux, PhD
- Email: dleroux@rivannamedical.com
- Phone: 804-514-0589
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.