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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Delphine Le Roux, PhD
- 전화번호: 804-514-0589
- 이메일: dleroux@rivannamedical.com
연구 장소
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California
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San Francisco, California, 미국, 94143
- 모병
- The University of California San Francisco
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연락하다:
- Elizabeth Butrick
- 전화번호: 4156016399
- 이메일: Elizabeth.butrick@ucsf.edu
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수석 연구원:
- Aaron Kornblith, MD
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Colorado
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Denver, Colorado, 미국, 80204
- 모병
- The University of Colorado Denver
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연락하다:
- Carolynn Lyle
- 전화번호: 3036025235
- 이메일: Carol.Lyle@dhha.org
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수석 연구원:
- Matthew Riscinti, MD
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Connecticut
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New Haven, Connecticut, 미국, 06510
- 모병
- Yale University
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연락하다:
- Ryan Denkewicz, MD
- 전화번호: 4013396076
- 이메일: ryan.denkewicz@yale.edu
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수석 연구원:
- Cristiana Baloescu, MD
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Illinois
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Chicago, Illinois, 미국, 60612
- 모병
- Rush University Medical Center
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수석 연구원:
- Michael Gottlieb, MD
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연락하다:
- Michael Gottlieb, MD
- 전화번호: (312) 952-6615
- 이메일: Michael_A_Gottlieb@rush.edu
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19107
- 모병
- Thomas Jefferson University Hospital
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연락하다:
- Nicole Renzi
- 전화번호: 215-955-2471
- 이메일: Nicole.renzi@jefferson.edu
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수석 연구원:
- Jason Fields, MD
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Texas
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Dallas, Texas, 미국, 75390
- 모병
- The University of Texas Southwestern
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연락하다:
- Riley Martin
- 전화번호: 2146482147
- 이메일: riley.martin@utsouthwestern.edu
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수석 연구원:
- Philip Jarrett, MD
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El Paso, Texas, 미국, 79905
- 모병
- Texas Tech University Health Sciences Center
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연락하다:
- Diluma Kariyawasam
- 전화번호: 9152154649
- 이메일: dkariyaw@ttuhsc.edu
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수석 연구원:
- Kara Samsel, MD
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Utah
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Salt Lake City, Utah, 미국, 84112
- 모병
- The University of Utah
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연락하다:
- Marina Griffith
- 전화번호: 8015298668
- 이메일: marina.griffith@hsc.utah.edu
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수석 연구원:
- Christopher Kelly, MD
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Virginia
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Charlottesville, Virginia, 미국, 22904
- 모병
- The University of Virginia
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연락하다:
- Ashley Simpson
- 전화번호: 4349242897
- 이메일: APS2H@uvahealth.org
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수석 연구원:
- Christopher Thom, MD
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Richmond, Virginia, 미국, 23298
- 모병
- Virginia Commonwealth University
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연락하다:
- Samuel Chun
- 전화번호: 8049555067
- 이메일: Samuel.Chun@vcuhealth.org
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수석 연구원:
- Jordan Tozer
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Accuro XV Image Quality Assessment
기간: 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
기간: 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
기간: 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.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Likert-Type Scale Participant-reported Imaging Modality Preference
기간: 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.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- Pro00075277
- 75A50121C00035 (기타 보조금/기금 번호: Biomedical Advanced Research Development Authority (BARDA))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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