[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656204":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":30,"studyPopulation":30,"armGroups":37,"interventions":44,"overallOfficials":50,"centralContacts":54,"locations":64,"responsibleParty":83,"collaborators":30,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":30,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":30,"studyType":100,"phases":101,"briefSummary":102,"conditions":103,"keywords":30,"overallStatus":66,"whyStopped":30,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Mayo Clinic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":30},[9,13],{"measure":10,"description":11,"timeFrame":12},"Feasibility of completing the CT-guided needle placement procedure using the LUMENA guidance system","Feasibility will be assessed as the proportion of procedures successfully completed using the LUMENA guidance system without withdrawal of the system before completion. The procedure will be considered feasible if more than 80% of procedures are completed using the system.","2 years",{"measure":14,"description":15,"timeFrame":12},"Safety of CT-guided needle placement using the LUMENA guidance system as assessed by adverse events","Safety will be assessed by the occurrence of serious adverse events and total adverse events associated with the procedure. The safety endpoint is safe needle placement in the target without any serious adverse events and total adverse events less than 10%.",[17,21,24,27],{"measure":18,"description":19,"timeFrame":20},"Accuracy of needle placement","Needle placement accuracy will be assessed by comparing the planned target location on the planning CT image set with the actual needle tip location on the confirmatory CT image set. Accuracy will be calculated as the three-dimensional distance between the planned target and actual needle tip location, reported in millimeters.","1 day",{"measure":22,"description":23,"timeFrame":20},"Procedure time","Procedure time will be measured from acquisition of the initial imaging to acquisition of the final imaging and reported in minutes.",{"measure":25,"description":26,"timeFrame":20},"Number of intermediary CT\u002Ffluoroscopy images","The number of intermediary CT\u002Ffluoroscopy images obtained during the procedure will be recorded as an indirect measure of radiation exposure.",{"measure":28,"description":29,"timeFrame":20},"Operator usability assessment of the LUMENA guidance system","At the end of each procedure, the operator will complete a usability form that captures ease of use using a Likert scale and subjective clinical impressions of system use and utility.",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"NA","SINGLE_GROUP","DEVICE_FEASIBILITY",{"masking":36,"maskingDescription":30,"whoMasked":30},"NONE",[38],{"label":39,"type":40,"description":41,"interventionNames":42},"LUMENA Augmented Reality Guidance","EXPERIMENTAL","Participants will undergo clinically indicated CT-guided needle placement for ablation or biopsy with use of the LUMENA augmented reality guidance system.",[43],"Device: LUMENA Guidance System",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":30},"DEVICE","LUMENA Guidance System","LUMENA is an augmented reality needle guidance system that provides real-time visual guidance during CT-guided needle placement procedures.",[39],[51],{"name":52,"affiliation":5,"role":53},"David Sella, MD","PRINCIPAL_INVESTIGATOR",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":30,"email":59},"Nic Dybel","CONTACT","904-953-4324","dybel.nicolas@mayo.edu",{"name":61,"role":57,"phone":62,"phoneExt":30,"email":63},"Julia Santos","904-953-3280","santos.julia@mayo.edu",[65],{"facility":5,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"RECRUITING","Jacksonville","Florida","32224","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-81.65565,30.33218,{"lat":76,"lon":75},[79,82],{"name":80,"role":57,"phone":81,"phoneExt":30,"email":30},"Riley Nichols","904-953-7783",{"name":52,"role":53,"phone":30,"phoneExt":30,"email":30},{"type":53,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"David Sella","Principal Investigator","100656204","a-study-of-augmented-reality-real-time-guidance-with-in-situ-feedback-100656204",false,"NCT07822425","A Study Of Augmented Reality Real-Time Guidance With In-situ Feedback","Augmented Reality Real-Time Guidance With In-situ Feedback","INCLUSION CRITERIA\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, ages 18-90 years\n* Patient referred to Interventional Radiology for CT-guided needle placement for ablation\u002Fbiopsy.\n\nEXCLUSION CRITERIA\n\n* Patients who are unable to give informed consent themselves or through their parents.\n* Patients that do not fit into the gantry of the CT scanner.\n* Patients who are sensitive to radiation exposure such as pregnant women.",true,"ALL","18 Years","90 Years",{"count":98,"type":99},10,"ESTIMATED","INTERVENTIONAL",[32],"The purpose of this study is to evaluate the feasibility and safety of using the LUMENA guidance system during clinical procedures in patients undergoing CT-guided needle Placement for kidney, liver, lymph node, abdominal mass and lung ablation\u002Fbiopsy.",[104,105],"Biopsy","Ablation","2026-09-10",{"date":108,"type":109},"2026-09-16","ACTUAL",{"date":111,"type":99},"2026-09-17",{"date":113,"type":99},"2028-09-16",{"name":5,"class":6},1]