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.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Delphine Le Roux, PhD
- Номер телефона: 804-514-0589
- Электронная почта: dleroux@rivannamedical.com
Места учебы
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California
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San Francisco, California, Соединенные Штаты, 94143
- Рекрутинг
- The University of California San Francisco
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Контакт:
- Elizabeth Butrick
- Номер телефона: 4156016399
- Электронная почта: Elizabeth.butrick@ucsf.edu
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Главный следователь:
- Aaron Kornblith, MD
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Colorado
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Denver, Colorado, Соединенные Штаты, 80204
- Рекрутинг
- The University of Colorado Denver
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Контакт:
- Carolynn Lyle
- Номер телефона: 3036025235
- Электронная почта: Carol.Lyle@dhha.org
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Главный следователь:
- Matthew Riscinti, MD
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Connecticut
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New Haven, Connecticut, Соединенные Штаты, 06510
- Рекрутинг
- Yale University
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Контакт:
- Ryan Denkewicz, MD
- Номер телефона: 4013396076
- Электронная почта: ryan.denkewicz@yale.edu
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Главный следователь:
- Cristiana Baloescu, MD
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Illinois
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Chicago, Illinois, Соединенные Штаты, 60612
- Рекрутинг
- Rush University Medical Center
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Главный следователь:
- Michael Gottlieb, MD
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Контакт:
- Michael Gottlieb, MD
- Номер телефона: (312) 952-6615
- Электронная почта: Michael_A_Gottlieb@rush.edu
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19107
- Рекрутинг
- Thomas Jefferson University Hospital
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Контакт:
- Nicole Renzi
- Номер телефона: 215-955-2471
- Электронная почта: Nicole.renzi@jefferson.edu
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Главный следователь:
- Jason Fields, MD
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Texas
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Dallas, Texas, Соединенные Штаты, 75390
- Рекрутинг
- The University of Texas Southwestern
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Контакт:
- Riley Martin
- Номер телефона: 2146482147
- Электронная почта: riley.martin@utsouthwestern.edu
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Главный следователь:
- Philip Jarrett, MD
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El Paso, Texas, Соединенные Штаты, 79905
- Рекрутинг
- Texas Tech University Health Sciences Center
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Контакт:
- Diluma Kariyawasam
- Номер телефона: 9152154649
- Электронная почта: dkariyaw@ttuhsc.edu
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Главный следователь:
- Kara Samsel, MD
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Utah
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Salt Lake City, Utah, Соединенные Штаты, 84112
- Рекрутинг
- The University of Utah
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Контакт:
- Marina Griffith
- Номер телефона: 8015298668
- Электронная почта: marina.griffith@hsc.utah.edu
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Главный следователь:
- Christopher Kelly, MD
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Virginia
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Charlottesville, Virginia, Соединенные Штаты, 22904
- Рекрутинг
- The University of Virginia
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Контакт:
- Ashley Simpson
- Номер телефона: 4349242897
- Электронная почта: APS2H@uvahealth.org
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Главный следователь:
- Christopher Thom, MD
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Richmond, Virginia, Соединенные Штаты, 23298
- Рекрутинг
- Virginia Commonwealth University
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Контакт:
- Samuel Chun
- Номер телефона: 8049555067
- Электронная почта: Samuel.Chun@vcuhealth.org
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Главный следователь:
- Jordan Tozer
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Accuro XV Image Quality Assessment
Временное ограничение: 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
Временное ограничение: 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.
|
|
Participant Comfort During Imaging
Временное ограничение: 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.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Likert-Type Scale Participant-reported Imaging Modality Preference
Временное ограничение: 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.
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- Pro00075277
- 75A50121C00035 (Другой номер гранта/финансирования: Biomedical Advanced Research Development Authority (BARDA))
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .