[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643405":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":87,"collaborators":10,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":10,"enrollmentInfo":99,"targetDuration":102,"studyType":103,"phases":10,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":111,"whyStopped":10,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"AnX Robotica Corp.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NaviCam VCE (video capsule endoscopy)",null,"Adults 22 years of age or older who received a NaviCam capsule endoscopy procedure",[13,14,15],"Device: Video capsule endoscopy","Other: Phase II = Data analysis by Independent Readers","Other: Phase III = Data Analysis by Expert Readers",[17,22,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":10},"DEVICE","Video capsule endoscopy","Phase I = Data Collection. The video from the capsule endoscopy procedure will be reviewed and reported by the treating physician. Once the capsule has passed and any adverse events have been collected, there will be no additional patient follow-up.",[9],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"OTHER","Phase II = Data analysis by Independent Readers","Independent video capsule readers to review and evaluate the videos from the capsule endoscopy procedure (Phase I), plus the ProScan videos.",[9],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"Phase III = Data Analysis by Expert Readers","An Expert Panel will read all videos to create a database comparing the Physician results (Phase I) and the ProScan + Physician results (Phase II).",[9],[32],{"name":33,"affiliation":34,"role":35},"Shabana Pasha, MD","Mayo Clinic","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":10,"email":41},"Tim Thomas, RAC","CONTACT","770-480-2911","tim.thomas@anxrobotics.com",[43,60,71],{"facility":44,"status":10,"city":45,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"NYU Langone Health","New York","10016","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-74.00597,40.71427,{"lat":53,"lon":52},[56],{"name":57,"role":39,"phone":58,"phoneExt":10,"email":59},"Melissa Latorre Debordeaux, MD MS","646-501-9795","Melissa.Debordeaux@nyulangone.org",{"facility":61,"status":10,"city":45,"state":45,"zip":62,"country":47,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"NYU Grossman School of Medicine","10022",{"type":50,"coordinates":64},[52,53],{"lat":53,"lon":52},[67],{"name":68,"role":39,"phone":69,"phoneExt":10,"email":70},"David Poppers, MD PhD","646-754-2000","david.poppers@nyulangone.org",{"facility":72,"status":10,"city":73,"state":74,"zip":75,"country":47,"countryCode":48,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Digestive Health Associates of Texas","Bedford","Texas","76002",{"type":50,"coordinates":77},[78,79],-97.14307,32.84402,{"lat":79,"lon":78},[82],{"name":83,"role":39,"phone":84,"phoneExt":85,"email":86},"Jay Yepuri, MD","817-267-8470","117","jay.yepuri@dhat.com",{"type":88,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100643405","a-post-market-trial-assessing-the-accuracy-of-normal-mode-reading-vs-proscan-reading-with-the-navicam-sb-system-this-is-a-comparison-of-retrospectively-obtained-capsule-endoscopy-videos-with-a-new-ai-reading-tool-no-new-interventions-will-be-completed-100643405",false,"NCT07633847","A Post Market Trial Assessing the Accuracy of Normal Mode Reading vs. ProScan Reading With the NaviCam SB System. This is a Comparison of Retrospectively Obtained Capsule Endoscopy Videos With a New AI Reading Tool; no New Interventions Will be Completed.","Prospective Study Exploring the Difference of AI-Trained Software Compared to Conventional Interpretation Methods in Small Bowel Video Capsule Procedures","PROCEED","Inclusion Criteria:\n\n* Patients of all genders, races, ethnicities and geographical backgrounds, from 22 years of age or older.\n* Patient agrees to sign informed consent and follow all study procedures.\n\nExclusion Criteria:\n\n* In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.\n* In patients with cardiac pacemakers or other implantable electronic medical devices (MR unsafe devices only).\n* In patients with dysphagia with high risk of aspiration.\n* In pregnant women.\n* GI motility issues (gastroparesis)\n* GI dysmotility\n* Chronic opioid usage\n* Requires endoscopic placement\n* In patients with endoscopic biopsies within one week of scheduled capsule ingestion\n* No NSAID use within 14 days of scheduled capsule ingestion\n* No GLP-1 drugs within 7 days of scheduled capsule ingestion","ALL","22 Years",{"count":100,"type":101},92,"ESTIMATED","14 Days","OBSERVATIONAL","NaviCam ProScan is an artificial intelligent (AI) assisted reading tool designed to aid small bowel capsule endoscopy reviewers in decreasing the time to review capsule endoscopy images for adult patients in whom the capsule endoscopy images were obtained for suspected small bowel bleeding.",[106],"Small Bowel Bleeding",[108,109,110],"artificial intelligent","assisted reading tool","capsule endoscopy","NOT_YET_RECRUITING","2026-06-05",{"date":114,"type":115},"2026-06-08","ACTUAL",{"date":117,"type":101},"2026-06-15",{"date":119,"type":101},"2028-09-15",{"name":5,"class":6},3]