[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601532":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":34,"locations":43,"responsibleParty":59,"collaborators":10,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":10,"studyType":76,"phases":10,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":45,"whyStopped":10,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Fondazione Poliambulanza Istituto Ospedaliero","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Suspected Crohn's Disease",null,"Eligible patients for the study are those with clinical symptoms and laboratory results suggestive of CD who have previously undergone an ileocolonoscopy which excluded other organic pathology and\u002For resulted inconclusive for CD (aspecific terminal ileitis).",[13],"Device: Small bowel Video Capsule Endoscopy (VCE) using an Capsule System equipped with a Deep Neural Network based system called SmartScan (SC),",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Small bowel Video Capsule Endoscopy (VCE) using an Capsule System equipped with a Deep Neural Network based system called SmartScan (SC),","Small bowel Video Capsule Endoscopy (VCE) will be performed using the an Capsule System equipped with a Deep Neural Network based system called SmartScan (SC), which is able to automatically select suspected lesions thus creating a very short video constituted only by selected images.",[9],[21,22],"Video Capsule Endoscopy (VCE)","DNN SmartScan system",[24,28,31],{"name":25,"affiliation":26,"role":27},"Cristiano Spada, Prof","Fondazione Poliambulanza, Policlinico A Gemelli","STUDY_DIRECTOR",{"name":29,"affiliation":30,"role":27},"Paola Cesaro, PhD","Fondazione Poliambulanza",{"name":32,"affiliation":30,"role":33},"Stefania Piccirelli, MD","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":10,"email":38},"CONTACT","0039 0303518364","stefania.piccirelli@poliambulanza.it",{"name":40,"role":36,"phone":41,"phoneExt":10,"email":42},"Clarissa Ferrari, PhD","0039 0303518610","clarissa.ferrari@poliambulanza.it",[44],{"facility":5,"status":45,"city":46,"state":10,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Brescia","25124","Italy","IT",{"type":51,"coordinates":52},"Point",[53,54],10.21472,45.53558,{"lat":54,"lon":53},[57],{"name":32,"role":36,"phone":58,"phoneExt":10,"email":38},"+390303518364",{"type":33,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Stefania Piccirelli","Principal Investigator","100601532","comparison-between-artificial-intelligence-and-standard-reading-to-investigate-suspected-crohn-disease-the-scai-study-100601532",false,"NCT07111715","Comparison Between Artificial Intelligence and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY","Comparison Between Artificial Intelligence Assisted Capsule Endoscopy and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY","SCAI","Inclusion Criteria:\n\n* Age \\>= 18 and \\\u003C= 75 years\n* Clinical suspicion of Crohn's Disease (CD) with\u002Fwithout occlusive symptoms\n* Ileocolonoscopy: negative examination, aspecific inflammatory findings\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Known diagnosis of CD\n* Endoscopic diagnosis of active diverticular disease, colorectal cancer, ulcerative colitis, or infectious colitis, microscopic colitis\n* Positive stool tests for pathogenic bacteria, Yersinia enterocolitica, parasites, C. difficile infection, fecal antigen for Giardia lamblia within 6 months before VCE\n* Known intestinal obstruction or unconfirmed small bowel patency\n* Any use of NSAIDs in the 4 weeks before ileocolonoscopy and before VCE\n* Known gastrointestinal motility disorder\n* Known or suspected delayed gastric emptying\n* Swallowing disorders\n* Allergy or other contraindications or intolerance to the medications\u002Fdevices used in the study\n* Endoscopic placement of the capsule\n* Any condition that prevents adherence to the study\n* Pregnancy\n* Participation in another clinical trial involving experimental drugs or devices\n* Concomitant life-threatening condition\n* Chronic kidney disease (eGFR\\\u003C30mL\u002Fmin\u002F1.73 m2)\n* Inability to sign the informed consent","ALL","18 Years","75 Years",{"count":74,"type":75},180,"ESTIMATED","OBSERVATIONAL","The diagnosis of Crohn's Disease (CD) is based on a combination of clinical, biochemical (serological and fecal), endoscopic, radiological, and histological investigations. In the absence of obstructive symptoms or known stenosis, European guidelines recommend to investigate the small intestine using Video Capsule Endoscopy (VCE) if ileocolonoscopy is not decisive. To reduce the reading time of VCE and increase the number of identified lesions during the examination, various artificial intelligence software\u002Ftools have been developed in recent decades. This study aims to be the first prospective multicentric real-life trial to evaluate AI-assisted VCE using SmartScan in identifying typical mucosal abnormalities of the small intestine in patients with suspected CD and its ability to reduce reading time while maintaining the same diagnostic yield and diagnostic accuracy of standard reading. The objective of the study is to evaluate the role of AI-assisted VCE using the OMOM SmartScan in detecting typical small bowel inflammatory lesions (i.e. erosions and ulcers) in patients with suspected CD, and comparing AI with standard reading.",[79],"Crohn Disease (CD)",[79,81,21],"Artificial Intelligence","2025-08-05",{"date":84,"type":85},"2025-08-08","ACTUAL",{"date":87,"type":85},"2025-07-21",{"date":89,"type":75},"2028-12-31",{"name":5,"class":6},1]