[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rivanna Medical, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":59},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100658795","accuro-xv-ultrasound-imaging-system-for-boneenhance-and-fracture-detection-algorithms-100658795",false,"NCT07853768","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","Sites are currently on two different protocol Revisions.\n\nInclusion Criteria\n\n* Age greater than or equal to 5 years.\n* The patient is presenting for distal limb injury of the wrist, forearm, ankle, or lower leg.\n* The patient is scheduled to receive an X-ray that includes a view of the ankle, lower leg, wrist, and\u002For forearm or any patient that received an X-ray accessible by the study team for the studied anatomy in the past 48 hours.\n* English and\u002For Spanish speaking.\n\nExclusion Criteria\n\n* An open fracture, grossly open wound, or severe angulation of the limb is present.\n* Patients for whom the site investigator feels that study participation could prohibit or impair ongoing medical care.\n* Known allergy to ultrasound couplants.","ALL","5 Years",{"count":19,"type":20},25000,"ESTIMATED","INTERVENTIONAL",[23],"NA","The Accuro XV is a cart-based, bedside ultrasound instrument that incorporates new signal processing-based technologies for enhanced bone and soft-tissue imaging.\n\nPatients 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.\n\nIn 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.\n\nThe Accuro XV is investigational in this study and is not intended to guide clinical decision-making.",[26,27,28,29],"Fracture Arm","Fracture Leg","Wrist Injury","Ankle Injury",[31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"distal extremity fracture","bone fracture","musculoskeletal injury","extremity trauma","ultrasound imaging","point-of-care ultrasound","volumetric ultrasound","3D ultrasound","bone imaging","soft tissue imaging","fracture detection","Accuro XV","Medical Device Feasibility","Image Quality","Algorithm Development","RECRUITING","2026-10-09",{"date":49,"type":50},"2026-10-13","ACTUAL",{"date":52,"type":50},"2024-01-29",{"date":54,"type":20},"2027-08",{"name":56,"class":57},"Rivanna Medical, Inc.","INDUSTRY",10,""]