NCT07853768 · Rivanna Medical, Inc.
Accuro XV Ultrasound Imaging System for BoneEnhance and Fracture Detection Algorithms
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Accuro XV Ultrasound Imaging System
The Accuro XV Ultrasound Imaging System is a cart-based ultrasound imaging device designed to acquire volumetric images of bone and soft tissue anatomy of the distal extremities. In this study, participants will undergo additional Accuro XV imaging following standard-of-care imaging for a distal extremity injury. The imaging procedure includes acquisition of multiple views of the injured anatomy using ultrasound technology and advanced image-processing methods to generate three-dimensional representations of bone and soft tissue structures. Images collected during the study will be used to evaluate device feasibility, safety, image quality, and to support the development and testing of future algorithms. Accuro XV imaging results will not be used for clinical decision-making.
Primary outcome measures
Accuro XV Image Quality Assessment
Time frame: From Accuro XV image acquisition through completion of retrospective image-quality assessment, up to 48 months.
Retrospective assessment of acquired Accuro XV images for artifacts and other visual imperfections to evaluate image quality and suitability for subsequent analysis and algorithm development.
Feasibility of Accuro XV Imaging Acquisition
Time frame: During and immediately after Accuro XV imaging on the day of enrollment.
Successful acquisition of Accuro XV images of the target distal extremity anatomy according to study procedures; site PIs, AIs, and other Accuro XV users will be queried on how Accuro XV fits into their clinical workflow in terms of usability, maneuverablity, reliability and more. Surveys to be developed.
Participant Comfort During Imaging
Time frame: Immediately after Accuro XV imaging on the day of enrollment.
Participant-reported comfort and pain scores associated with Accuro XV imaging collected through the participant questionnaire. Participants completed a questionnaire assessing pain associated with both standard-of-care imaging and Accuro XV scanning. Specifically, participants were asked to rate their pain (1) before standard-of-care imaging, (2) during standard-of-care imaging, (3) before Accuro XV scans, and (4) during Accuro XV scans. Pain was measured using an 11-point Likert-type scale ranging from 0 ("none") to 10 ("severe"), with higher scores indicating greater pain.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- San Francisco, California
- Denver, Colorado
- New Haven, Connecticut
- Dallas, Texas
- El Paso, Texas
- Salt Lake City, Utah
- Charlottesville, Virginia
- Richmond, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 2, 2026 · Source of record for eligibility and locations