[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06564571":3,"trial-entities:NCT06564571":92,"trial-summary:NCT06564571":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":38,"secondary_outcomes":43,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":14,"eligibility_criteria":53,"std_ages":60,"locations":63,"central_contacts":83,"overall_officials":86,"references":90,"see_also_links":91},"NCT06564571","24.015.01","Artificial Intelligence in Endoscopic Ultrasound","RECRUITING","2027-12","2024-08","2025-05-31","2024-01-19","Orlando Health, Inc.","OTHER",false,"The objective of the study is to determine if this artificial intelligence system is capable of detecting abnormalities in the pancreas that are identified by an endoscopist at endoscopic ultrasound procedures.","Endoscopic Ultrasound (EUS) is an equipment where an ultrasound transducer is attached to the tip of the endoscope. When advanced to the stomach the organs outside such as the pancreas and liver can be visualized in great detail. This enables diagnosis of conditions such as pancreatic cancer. However, an endoscopist must undergo training to accurately interpret these ultrasound images.\n\nThe investigators are in the process of developing an artificial intelligence system that could potentially interpret EUS images. The objective of the study is to determine if this artificial intelligence system is capable of detecting abnormalities in the pancreas that are identified by an endoscopist at endoscopic ultrasound procedures. Such correlation if established will lead to possible development of an artificial intelligence platform that can diagnose pancreatic diseases. Such development will potentially minimize human error and decrease learning curve to gain proficiency in EUS.",[18,19,20],"Pancreatic Cancer","Pancreas Disease","Pancreatic Cyst",[22,23,24,25],"pancreatic disease","pancreatic cancer","pancreatic cyst","artificial intelligence","OBSERVATIONAL",null,[],{"count":30,"type":31},310,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DEVICE","Patients undergoing endoscopic ultrasound procedures","Patients will undergo endoscopic ultrasound procedures as planned. Abnormalities in the pancreas identified by the endoscopist during the endoscopic ultrasound examination will be correlated against those detected by the AI platform.",[35],[39],{"measure":40,"description":41,"timeFrame":42},"Rate of detection pancreatic abnormalities by AI","Ability of AI to detect pancreatic abnormalities as identified by an endoscopist during EUS examination of the pancreas.","1 day",[44,47],{"measure":45,"description":46,"timeFrame":42},"Rate of detection pancreatic solid mass lesions by AI","Ability of AI to detect pancreatic solid mass lesions as identified by an endoscopist during EUS examination of the pancreas.",{"measure":48,"description":49,"timeFrame":42},"Rate of detection pancreatic cystic lesions by AI","Ability of AI to detect pancreatic cystic lesions as identified by an endoscopist during EUS examination of the pancreas.","ALL","18 Years","100 Years",{"inclusion":54,"exclusion":57,"raw_text":59},[55,56],"Age ≥ 18 years","Any patient undergoing endoscopic ultrasound examination",[58],"Age \\\u003C 18 years","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Any patient undergoing endoscopic ultrasound examination\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years",[61,62],"ADULT","OLDER_ADULT",[64],{"facility":65,"status":7,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":80},"Orlando Health","Orlando","Florida","32806","United States",[71,76],{"name":72,"role":73,"phone":74,"email":75},"Shyam Varadarajulu, MD","CONTACT","321-841-2431","shyam.varadarajulu@orlandohealth.com",{"name":77,"role":73,"phone":78,"email":79},"Barbara Broome","321-841-4356","barbara.broome@orlandohealth.com",{"lat":81,"lon":82},28.53834,-81.37924,[84,85],{"name":72,"role":73,"phone":74,"email":75},{"name":77,"role":73,"phone":78,"email":79},[87],{"name":72,"affiliation":88,"role":89},"Orlando Health, Digestive Health Institute","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":93,"biomarkers":95},[94,20],"Pancreatic Carcinoma",[],{"nct_id":4,"found":97,"summary":98,"prompt_version":108},true,{"design":99,"status":100,"heading":101,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is an observational study involving 310 participants. It is designed to compare what an AI system detects during an endoscopic ultrasound with what a doctor detects.","completed","Artificial Intelligence in Endoscopic Ultrasound for Pancreatic Conditions","This study is looking at how well an artificial intelligence (AI) system can find problems in the pancreas during an endoscopic ultrasound (EUS) procedure. An EUS uses a special camera with an ultrasound on the end to look closely at organs like the pancreas. Doctors (endoscopists) already use EUS to diagnose conditions like pancreatic cancer. This study wants to see if the AI system can detect the same abnormalities that an endoscopist finds. The goal is to see if AI could help doctors interpret these images, potentially reducing errors and making it easier to learn how to use EUS. You can join if you are 18 years or older and are already having an EUS examination. The study will measure how many pancreatic abnormalities the AI detects within one day.","The primary endpoint, the rate of detection of pancreatic abnormalities by AI, is measured at 1 day.",130,"You will undergo an endoscopic ultrasound procedure as planned. The study will then compare what the AI platform detects with what your doctor identifies during that procedure.","Not stated in the trial record.",[],"v2"]