Accuro XV Ultrasound Imaging System for BoneEnhance and Fracture Detection Algorithms

NCT07853768 | Recruiting FDA Device

• 2 other identifiers: Pro0007527775A50121C00035
• Study Type: interventional
• Target: 25,000
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Fracture Arm; Fracture Leg; Wrist Injury; Ankle Injury

Keywords

distal extremity fracture; bone fracture; musculoskeletal injury; extremity trauma; ultrasound imaging; point-of-care ultrasound; volumetric ultrasound; 3D ultrasound; bone imaging; soft tissue imaging; fracture detection; Accuro XV; Medical Device Feasibility; Image Quality; Algorithm Development

Outcome Measures

Primary Outcomes (3)

• Accuro XV Image Quality Assessment

  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.

  From Accuro XV image acquisition through completion of retrospective image-quality assessment, up to 48 months.

• Feasibility of Accuro XV Imaging Acquisition

  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.

  During and immediately after Accuro XV imaging on the day of enrollment.

• Participant Comfort During Imaging

  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.

  Immediately after Accuro XV imaging on the day of enrollment.

Secondary Outcomes (1)

• Likert-Type Scale Participant-reported Imaging Modality Preference

  Immediately after Accuro XV imaging on the day of enrollment.

Study Arms (1)

Accuro XV Imaging

EXPERIMENTAL

Participants with a distal extremity injury who have undergone standard-of-care imaging will receive additional imaging with the Accuro XV ultrasound imaging system. Accuro XV imaging will be performed after completion of standard-of-care clinical imaging and will not be used for clinical decision-making or patient management. Imaging data collected during the study will be used to evaluate device feasibility, safety, image quality, and to support the development and testing of future algorithms.

Device: Accuro XV Ultrasound Imaging System

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.

Accuro XV Imaging

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rivanna Medical, Inc.: lead

Study Sites (8)

The University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

The University of Colorado Denver

Denver, Colorado, 80204, United States

RECRUITING

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

The University of Texas Southwestern

Dallas, Texas, 75390, United States

RECRUITING

Texas Tech University Health Sciences Center

El Paso, Texas, 79905, United States

RECRUITING

The University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

The University of Virginia

Charlottesville, Virginia, 22904, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Wrist Injuries; Ankle Injuries; Fractures, Bone

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Leg Injuries

Central Study Contacts

Joseph Kilroy, PhD

CONTACT

804-514-0589; programs@rivannamedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled participants receive the same intervention: Accuro XV imaging after standard-of-care imaging and informed consent. There is no randomization. There are no comparison groups or control arms. There is no crossover between interventions. The study is a prospective, single-arm feasibility study. Participants who meet eligibility criteria undergo Accuro XV imaging and contribute imaging data for safety, feasibility, and algorithm development.

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: October 2, 2026
• Study Start: January 29, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)