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Accuro XV Ultrasound Imaging System for BoneEnhance and Fracture Detection Algorithms

Rivanna Medical, Inc. · NCT07853768

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 5+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
25000
US sites recruiting
10
Study start
January 29, 2024
Record last updated
October 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the 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., 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.

Being studied: Accuro XV Ultrasound Imaging System

Conditions: Fracture Arm; Fracture Leg; Wrist Injury; Ankle Injury

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • The University of California San Francisco

    San Francisco, CA 94143

    Site contact: Elizabeth Butrick · 4156016399 · Elizabeth.butrick@ucsf.edu

  • The University of Colorado Denver

    Denver, CO 80204

    Site contact: Carolynn Lyle · 3036025235 · Carol.Lyle@dhha.org

  • Yale University

    New Haven, CT 06510

    Site contact: Ryan Denkewicz, MD · 4013396076 · ryan.denkewicz@yale.edu

  • Rush University Medical Center

    Chicago, IL 60612

    Site contact: Michael Gottlieb, MD · (312) 952-6615 · Michael_A_Gottlieb@rush.edu

  • Thomas Jefferson University Hospital

    Philadelphia, PA 19107

    Site contact: Nicole Renzi · 215-955-2471 · Nicole.renzi@jefferson.edu

  • The University of Texas Southwestern

    Dallas, TX 75390

    Site contact: Riley Martin · 2146482147 · riley.martin@utsouthwestern.edu

  • Texas Tech University Health Sciences Center

    El Paso, TX 79905

    Site contact: Diluma Kariyawasam · 9152154649 · dkariyaw@ttuhsc.edu

  • The University of Utah

    Salt Lake City, UT 84112

    Site contact: Marina Griffith · 8015298668 · marina.griffith@hsc.utah.edu

  • The University of Virginia

    Charlottesville, VA 22904

    Site contact: Ashley Simpson · 4349242897 · APS2H@uvahealth.org

  • Virginia Commonwealth University

    Richmond, VA 23298

    Site contact: Samuel Chun · 8049555067 · Samuel.Chun@vcuhealth.org

Study contacts (from the official record)

  • Delphine Le Roux, PhD · 804-514-0589 · dleroux@rivannamedical.com
Accuro XV Ultrasound Imaging System for BoneEnhance and Fracture… (NCT07853768) | Bored Studies