[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594901":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":48,"collaborators":19,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":19,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":78,"whyStopped":19,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"BelleTorus Corporation","INDUSTRY",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"Standard of care","OTHER",[12],"Diagnostic Test: Smartphone-enabled otoscopy",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DIAGNOSTIC_TEST","Smartphone-enabled otoscopy","Belle AI for ear image assessment",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Franco Barsanti, PharmD","CONTACT","+1 (347) 446-0227","franco.barsanti@urbanhealthplan.org",[27],{"facility":28,"status":19,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Urban Health Plan, Inc.","The Bronx","New York","10459","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-73.86641,40.84985,{"lat":38,"lon":37},[41,42,46],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},{"name":43,"role":23,"phone":44,"phoneExt":19,"email":45},"Carina Puello, BSN RN","+1 (718) 251-0223","carina.puello@urbanhealthplan.org",{"name":22,"role":47,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"type":49,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100594901","application-of-the-belleai-comparative-image-reference-system-for-describing-chronic-ear-infections-in-pediatric-patients-from-low-resource-communities-100594901",false,"NCT07025473","Application of the Belle.AI Comparative Image Reference System for Describing Chronic Ear Infections in Pediatric Patients From Low-Resource Communities","Application of the Belle.AI Comparative Image Reference System for Describing Chronic Ear Infections in Pediatric Patients From Low-Resource Communities in Remote, At-Home Settings","Otoscopy AI","Inclusion Criteria:\n\n* Patient must be aged 1 to 17 years old.\n* Patient must present with a primary middle ear complaint.\n* Parent of the pediatric patient must have the ability and willingness to provide informed consent and comply with study procedures and visits.\n* Participants must have access to the required technology (e.g., smartphone with internet access) and be capable of using the provided off-the-shelf otoscope for the required image capture.\n\nExclusion Criteria:\n\n• Patients who are unable to comply with study procedures due to physical or mental health limitations (as assessed by study coordinator).","ALL","1 Year","17 Years",{"count":62,"type":63},20,"ESTIMATED","INTERVENTIONAL",[66],"NA","The purpose of this research is to examine the clinical effectiveness of an investigational AI-powered smartphone app that describes the physical characteristics of an otoscopy image. It is not intended to make any diagnosis. Only healthcare professionals will make the diagnosis. The investigators will compare the diagnosis made by physicians or physician extenders (healthcare professionals) against the description provided by the support AI app tool to determine the clinical relevance of the system and examine its use within a clinical setting.",[69],"Ear Infection",[71,72,73,74,75,76,77],"AI","Artificial Intelligence","Digital Health","Ear Disorders","Otoscopy","Digital Videoscope","Ear Health","NOT_YET_RECRUITING","2025-06-13",{"date":81,"type":82},"2025-06-17","ACTUAL",{"date":84,"type":63},"2025-06-30",{"date":86,"type":63},"2025-09-30",{"name":5,"class":6},1]