[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100440696":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":29,"responsibleParty":52,"collaborators":10,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":10,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Prospective enrollment",null,"All subjects will be enrolled prospectively. Subjects will be included in the study after eligibility is assessed and informed consent is obtained. The slide scanner will scan the slides on site and the images will be securely saved and sent for interpretation by the AI software at a different location. The results of the AI interpretation of the slides will be blinded to the on-site procedure team including the endoscopist and cytopathologist until the final pathology report is complete.",[13],"Other: Artificial Intelligence software ROSE",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Artificial Intelligence software ROSE","Rapid on-site evaluation (ROSE) of Endoscopic Ultrasound (EUS) guided FNA\u002FFNB (Fine Needle Aspirate\u002FFine Needle Biopsy) of pancreatic solid lesions (PSLs) has been shown in improve diagnostic yield. The availability and performance of ROSE at EUS performing centers is variable. With strides in Artificial Intelligence (AI) capabilities over the years, the University of Texas at Health Sciences Center at Houston in collaboration with Haystac is developing an artificial intelligence based proprietary system to analyze slides from EUS FNA\u002FFNB samples at bedside.",[9],[20],{"name":21,"affiliation":5,"role":22},"Nirav Thosani, MD, MHA","PRINCIPAL_INVESTIGATOR",[24],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Prithvi B Patil, MS","CONTACT","7135006456","prithvi.b.patil@uth.tmc.edu",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Memorial Hermann Hospital","RECRUITING","Houston","Texas","77030","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-95.36327,29.76328,{"lat":42,"lon":41},[45,48,50],{"name":46,"role":26,"phone":47,"phoneExt":10,"email":28},"Prithvi B Patil","713-480-1179",{"name":49,"role":26,"phone":27,"phoneExt":10,"email":28},"Prithvi Patil, MS",{"name":51,"role":22,"phone":10,"phoneExt":10,"email":10},"Nirav Thosani, MD,MHA",{"type":22,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Nirav C Thosani","Associate Professor","100440696","artificial-intelligence-ai-cytopathology-trial-100440696",false,"NCT05018663","Artificial Intelligence (AI) Cytopathology Trial","Artificial Intelligence for Rapid On-site Evaluation (AI-ROSE) for Endoscopic Ultrasound-guided Fine-needle Aspiration (EUS-FNA) Biopsy of Pancreatic Solid Lesions: A Prospective Double Blinded Study","Inclusion Criteria:\n\n* Have EUS finding of a PSL;\n* Do not have contraindications for FNA\u002FFNB.\n\nExclusion Criteria:\n\n* Inability to provide informed consent for the procedure;\n* Contraindication for FNA\u002FFNB eg coagulopathy, lack of avascular window for FNA.","ALL","18 Years","100 Years",{"count":66,"type":67},50,"ESTIMATED","OBSERVATIONAL","Purpose The primary objective of the study is to compare interpretation of EUS FNA\u002FFNB samples for adequacy between ROSE and AI at bedside. To compare accuracy of preliminary diagnosis results between ROSE and AI at bedside versus final pathology report.\n\nResearch design This is a prospective single center study to compare performance characteristics in the interpretation of EUS FNA\u002FFNB samples between AI and ROSE.\n\nProcedures to be used Eligible patients will undergo EUS guided FNA\u002FFNA of PSLs using standard of care. Sample slides are prepared by a cytopathologist at bedside and observed under a microscope. At the same time, the slides are scanned using a slide scanner and those images are saved for interpretation by AI at a later time.",[71],"Pancreatic Solid Lesions",[73,74],"Endoscopic Ultrasound guided fine needle aspiration (FNA)","Endoscopic Ultrasound guided fine needle biopsy (FNB)","2023-02-15",{"date":77,"type":78},"2023-02-16","ACTUAL",{"date":80,"type":78},"2021-07-21",{"date":82,"type":67},"2028-01-30",{"name":5,"class":6},1]