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Accuro XV Ultrasound Imaging System for BoneEnhance and Fracture Detection Algorithms

13 octobre 2026 mis à jour par: Rivanna Medical, Inc.

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.

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

25000

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • California
      • San Francisco, California, États-Unis, 94143
        • Recrutement
        • The University of California San Francisco
        • Contact:
        • Chercheur principal:
          • Aaron Kornblith, MD
    • Colorado
      • Denver, Colorado, États-Unis, 80204
        • Recrutement
        • The University of Colorado Denver
        • Contact:
        • Chercheur principal:
          • Matthew Riscinti, MD
    • Connecticut
      • New Haven, Connecticut, États-Unis, 06510
        • Recrutement
        • Yale University
        • Contact:
        • Chercheur principal:
          • Cristiana Baloescu, MD
    • Illinois
      • Chicago, Illinois, États-Unis, 60612
        • Recrutement
        • Rush University Medical Center
        • Chercheur principal:
          • Michael Gottlieb, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19107
        • Recrutement
        • Thomas Jefferson University Hospital
        • Contact:
        • Chercheur principal:
          • Jason Fields, MD
    • Texas
      • Dallas, Texas, États-Unis, 75390
        • Recrutement
        • The University of Texas Southwestern
        • Contact:
        • Chercheur principal:
          • Philip Jarrett, MD
      • El Paso, Texas, États-Unis, 79905
        • Recrutement
        • Texas Tech University Health Sciences Center
        • Contact:
        • Chercheur principal:
          • Kara Samsel, MD
    • Utah
      • Salt Lake City, Utah, États-Unis, 84112
        • Recrutement
        • The University of Utah
        • Contact:
        • Chercheur principal:
          • Christopher Kelly, MD
    • Virginia
      • Charlottesville, Virginia, États-Unis, 22904
        • Recrutement
        • The University of Virginia
        • Contact:
        • Chercheur principal:
          • Christopher Thom, MD
      • Richmond, Virginia, États-Unis, 23298
        • Recrutement
        • Virginia Commonwealth University
        • Contact:
        • Chercheur principal:
          • Jordan Tozer

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

5 ans et plus (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Accuro XV Image Quality Assessment
Délai: From Accuro XV image acquisition through completion of retrospective image-quality assessment, up to 48 months.

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

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
Délai: Immediately after Accuro XV imaging on the day of enrollment.

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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Likert-Type Scale Participant-reported Imaging Modality Preference
Délai: Immediately after Accuro XV imaging on the day of enrollment.

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.
Immediately after Accuro XV imaging on the day of enrollment.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Rivanna Medical, Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 janvier 2024

Achèvement primaire (Estimé)

1 août 2027

Achèvement de l'étude (Estimé)

1 août 2027

Dates d'inscription aux études

Première soumission

3 juin 2026

Première soumission répondant aux critères de contrôle qualité

29 septembre 2026

Première publication (Réel)

2 octobre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Pro00075277
  • 75A50121C00035 (Autre subvention/numéro de financement: Biomedical Advanced Research Development Authority (BARDA))

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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