Accuro XV Ultrasound Imaging System for BoneEnhance and Fracture Detection Algorithms
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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Delphine Le Roux, PhD
- Telefonní číslo: 804-514-0589
- E-mail: dleroux@rivannamedical.com
Studijní místa
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California
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San Francisco, California, Spojené státy, 94143
- Nábor
- The University of California San Francisco
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Kontakt:
- Elizabeth Butrick
- Telefonní číslo: 4156016399
- E-mail: Elizabeth.butrick@ucsf.edu
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Vrchní vyšetřovatel:
- Aaron Kornblith, MD
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Colorado
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Denver, Colorado, Spojené státy, 80204
- Nábor
- The University of Colorado Denver
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Kontakt:
- Carolynn Lyle
- Telefonní číslo: 3036025235
- E-mail: Carol.Lyle@dhha.org
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Vrchní vyšetřovatel:
- Matthew Riscinti, MD
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Connecticut
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New Haven, Connecticut, Spojené státy, 06510
- Nábor
- Yale University
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Kontakt:
- Ryan Denkewicz, MD
- Telefonní číslo: 4013396076
- E-mail: ryan.denkewicz@yale.edu
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Vrchní vyšetřovatel:
- Cristiana Baloescu, MD
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Illinois
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Chicago, Illinois, Spojené státy, 60612
- Nábor
- Rush University Medical Center
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Vrchní vyšetřovatel:
- Michael Gottlieb, MD
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Kontakt:
- Michael Gottlieb, MD
- Telefonní číslo: (312) 952-6615
- E-mail: Michael_A_Gottlieb@rush.edu
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19107
- Nábor
- Thomas Jefferson University Hospital
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Kontakt:
- Nicole Renzi
- Telefonní číslo: 215-955-2471
- E-mail: Nicole.renzi@jefferson.edu
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Vrchní vyšetřovatel:
- Jason Fields, MD
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Texas
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Dallas, Texas, Spojené státy, 75390
- Nábor
- The University of Texas Southwestern
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Kontakt:
- Riley Martin
- Telefonní číslo: 2146482147
- E-mail: riley.martin@utsouthwestern.edu
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Vrchní vyšetřovatel:
- Philip Jarrett, MD
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El Paso, Texas, Spojené státy, 79905
- Nábor
- Texas Tech University Health Sciences Center
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Kontakt:
- Diluma Kariyawasam
- Telefonní číslo: 9152154649
- E-mail: dkariyaw@ttuhsc.edu
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Vrchní vyšetřovatel:
- Kara Samsel, MD
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Utah
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Salt Lake City, Utah, Spojené státy, 84112
- Nábor
- The University of Utah
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Kontakt:
- Marina Griffith
- Telefonní číslo: 8015298668
- E-mail: marina.griffith@hsc.utah.edu
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Vrchní vyšetřovatel:
- Christopher Kelly, MD
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Virginia
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Charlottesville, Virginia, Spojené státy, 22904
- Nábor
- The University of Virginia
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Kontakt:
- Ashley Simpson
- Telefonní číslo: 4349242897
- E-mail: APS2H@uvahealth.org
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Vrchní vyšetřovatel:
- Christopher Thom, MD
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Richmond, Virginia, Spojené státy, 23298
- Nábor
- Virginia Commonwealth University
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Kontakt:
- Samuel Chun
- Telefonní číslo: 8049555067
- E-mail: Samuel.Chun@vcuhealth.org
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Vrchní vyšetřovatel:
- Jordan Tozer
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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. |
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Accuro XV Image Quality Assessment
Časové okno: From Accuro XV image acquisition through completion of retrospective image-quality assessment, up to 48 months.
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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.
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Feasibility of Accuro XV Imaging Acquisition
Časové okno: During and immediately after Accuro XV imaging on the day of enrollment.
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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.
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Participant Comfort During Imaging
Časové okno: Immediately after Accuro XV imaging on the day of enrollment.
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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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Likert-Type Scale Participant-reported Imaging Modality Preference
Časové okno: Immediately after Accuro XV imaging on the day of enrollment.
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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.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Pro00075277
- 75A50121C00035 (Jiné číslo grantu/financování: Biomedical Advanced Research Development Authority (BARDA))
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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