Recruiting

Accuro XV

Sponsor:

Rivanna Medical, Inc.

Code:

NCT07853768

Conditions

Fracture Arm

Fracture Leg

Wrist Injury

Ankle Injury

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

Interventions

Accuro XV Ultrasound Imaging System

Study Details

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

Study ID

NCT07853768

Start date

Jan 29, 2024

Status verified date

Sep, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Accuro XV Imaging

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.

Interventions

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 measure

  • Accuro XV Image Quality Assessment [ Time Frame: From Accuro XV image acquisition through completion of retrospective image-quality assessment, up to 48 months. ]
  • Feasibility of Accuro XV Imaging Acquisition [ Time Frame: During and immediately after Accuro XV imaging on the day of enrollment. ]
  • Participant Comfort During Imaging [ Time Frame: Immediately after Accuro XV imaging on the day of enrollment. ]

Central Contacts and Locations

Central contacts

Joseph Kilroy, PhD

804-514-0589programs@rivannamedical.com

Locations

The University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Elizabeth Butrick

4156016399Elizabeth.butrick@ucsf.edu

Principal Investigator:

Aaron Kornblith, MD

The University of Colorado Denver

Recruiting

Denver, Colorado, United States, 80204

Contacts

Carolynn Lyle

3036025235Carol.Lyle@dhha.org

Principal Investigator:

Matthew Riscinti, MD

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Ryan Denkewicz, MD

4013396076ryan.denkewicz@yale.edu

Principal Investigator:

Cristiana Baloescu, MD

The University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Riley Martin

2146482147riley.martin@utsouthwestern.edu

Principal Investigator:

Philip Jarrett, MD

Texas Tech University Health Sciences Center

Recruiting

El Paso, Texas, United States, 79905

Contacts

Diluma Kariyawasam

9152154649dkariyaw@ttuhsc.edu

Principal Investigator:

Edward Michelson, MD

The University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Marina Griffith

8015298668marina.griffith@hsc.utah.edu

Principal Investigator:

Christopher Kelly, MD

The University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22904

Contacts

Ashley Simpson

4349242897APS2H@uvahealth.org

Principal Investigator:

Christopher Thom, MD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Samuel Chun

8049555067Samuel.Chun@vcuhealth.org

Principal Investigator:

Jordan Tozer

More Information

Sponsor

Rivanna Medical, Inc.

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Rivanna Medical, Inc. on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.