Accuro XV Ultrasound Imaging System for BoneEnhance and Fracture Detection Algorithms

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, investigators 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. Investigators 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

• Accuro XV Ultrasound Imaging System (Device)
  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.

Eligibility criteria

Conditions

Locations

• The University of California San Francisco — San Francisco, California, United States
• The University of Colorado Denver — Denver, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• The University of Texas Southwestern — Dallas, Texas, United States
• Texas Tech University Health Sciences Center — El Paso, Texas, United States
• The University of Utah — Salt Lake City, Utah, United States
• The University of Virginia — Charlottesville, Virginia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States