Accuro XV Ultrasound Imaging System for BoneEnhance and Fracture Detection Algorithms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5+
SponsorRivanna Medical, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Accuro XV Ultrasound Imaging System
DeviceThe 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.
Treatment groups
25,000 Participants
are divided into 1 treatment groupGroup A: Accuro XV ImagingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From Accuro XV image acquisition through completion of retrospective image-quality assessment, up to 48 months.2
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.
Time frame
During and immediately after Accuro XV imaging on the day of enrollment.3
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.
Time frame
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.
Time frame
Immediately after Accuro XV imaging on the day of enrollment.Sponsors and contacts
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Source ClinicalTrials.gov