Fracture ArmNCT07853768
Accuro XV Ultrasound Imaging System for BoneEnhance and Fracture Detection Algorithms
A study testing Accuro XV Ultrasound Imaging System in people with Fracture Arm and Fracture Leg, run by Rivanna Medical, Inc. at 10 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Fracture Arm, Fracture Leg, Wrist Injury
- What is being tested?
- Accuro XV Ultrasound Imaging System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25,000 participants
- Where
- 10 sitesUnited States
- Study dates
- 29 Jan 2024to Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
The University of Virginia
Charlottesville, Virginia, 22904
Ashley Simpson, 4349242897, APS2H@uvahealth.org
Christopher Thom, MD
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Michael Gottlieb, MD, (312) 952-6615, Michael_A_Gottlieb@rush.edu
Michael Gottlieb, MD
- Recruiting
The University of Texas Southwestern
Dallas, Texas, 75390
Riley Martin, 2146482147, riley.martin@utsouthwestern.edu
Philip Jarrett, MD
- Recruiting
The University of Colorado Denver
Denver, Colorado, 80204
Carolynn Lyle, 3036025235, Carol.Lyle@dhha.org
Matthew Riscinti, MD
- Recruiting
Texas Tech University Health Sciences Center
El Paso, Texas, 79905
Diluma Kariyawasam, 9152154649, dkariyaw@ttuhsc.edu
Kara Samsel, MD
- Recruiting
Yale University
New Haven, Connecticut, 06510
Ryan Denkewicz, MD, 4013396076, ryan.denkewicz@yale.edu
Cristiana Baloescu, MD
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Nicole Renzi, 215-955-2471, Nicole.renzi@jefferson.edu
Jason Fields, MD
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Samuel Chun, 8049555067, Samuel.Chun@vcuhealth.org
Jordan Tozer
- Recruiting
The University of Utah
Salt Lake City, Utah, 84112
Marina Griffith, 8015298668, marina.griffith@hsc.utah.edu
Christopher Kelly, MD
- Recruiting
The University of California San Francisco
San Francisco, California, 94143
Elizabeth Butrick, 4156016399, Elizabeth.butrick@ucsf.edu
Aaron Kornblith, MD
About this study
Official title: MSK Injury Assessment Imaging System: Feasibility and Data Acquisition for Algorithm Development and Testing
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.
Read more
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.
- Conditions
- Fracture Arm, Fracture Leg, Wrist Injury, Ankle Injury
- Being tested
- Accuro XV Ultrasound Imaging System
- 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
- Medical subject headings
- Wrist Injuries, Ankle Injuries, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accuro XV Ultrasound Imaging SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Accuro XV Ultrasound Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Immediately after Accuro XV imaging on the day of enrollment.
Secondary outcomes (1)
Likert-Type Scale Participant-reported Imaging Modality Preference
Participant-reported preference between Accuro XV imaging and standard-of-care imaging modalities. Participants completed a questionnaire assessing satisfaction with both standard-of-care imaging and Accuro XV scanning. Participants were asked to rate their satisfaction with each imaging modality on an 11-point Likert-type scale ranging from 0 ("not satisfied at all") to 10 ("very satisfied"), with higher scores indicating greater satisfaction. In addition, participants were asked to indicate their preferred imaging modality by selecting either Accuro XV, standard-of-care imaging, or no preference.
Measured: Immediately after Accuro XV imaging on the day of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start29 Jan 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture ArmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rivanna Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853768
- Sponsor's protocol ID
- Pro00075277
- Other IDs
- 75A50121C00035
- Status last verified
- Oct 2026
- First submitted
- 3 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No