[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637973":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":19,"responsibleParty":20,"collaborators":19,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":29,"acronym":19,"eligibilityCriteria":30,"healthyVolunteers":26,"sex":31,"minAge":32,"maxAge":33,"enrollmentInfo":34,"targetDuration":19,"studyType":37,"phases":38,"briefSummary":40,"conditions":41,"keywords":19,"overallStatus":44,"whyStopped":19,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":19},{"fullName":5,"class":6},"The Hospital for Sick Children","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"AI Model Intervention Arm","EXPERIMENTAL","When children with HN are seen in clinic, their ultrasound imaging and history will be provided to an initial clinician who will first formulate a plan of care without access to the AI model as per the standard of care. After the initial plan is documented and before discussion with the primary provider, the initial clinician will then be granted access to the AI model, where they can input the ultrasound images and receive the model's prediction. The clinician can choose to modify or maintain their drafted plan based on the model's output. The clinician's final drafted plan will subsequently be discussed with the blinded final clinical expert (primary provider) who will make the final decision to maintain the standard of care for each patient. The final clinical expert will be blinded to whether the initial clinician changed their plan or not given the AI model",[13],"Other: Machine learning model",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Machine learning model","The AI intervention is a deep learning algorithm used to predict obstructive hydronephrosis. It was developed at SickKids and has recently completed the silent trial phase. This clinical trial aims to validate the model's clinical integration by assessing its impact on clinician decision-making and care plan recommendations. To uphold standard care, a blinded clinician will make final decisions.",[9],null,{"type":21,"investigatorFullName":22,"investigatorTitle":23,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Mandy Rickard","Nurse Practitioner","100637973","integrating-an-ai-driven-hydronephrosis-decision-making-tool-100637973",false,"NCT07581223","Integrating an AI-Driven Hydronephrosis Decision-Making Tool","Integration of a Hydronephrosis AI-Driven Decision-Making Tool Into Clinical Practice: A Clinical Trial","Inclusion Criteria:\n\n* Seen for HN in-person in the Pediatric Urology clinic with ultrasound scans taken at SickKids\n* New and follow-up patients 0-24 months.\n\nExclusion Criteria:\n\n* Older than 24m\n* Concurrent urinary tract anomalies (duplex configurations; PUV etc.)\n* History of renal surgical intervention (post-op patients)","ALL","0 Months","24 Months",{"count":35,"type":36},322,"ESTIMATED","INTERVENTIONAL",[39],"NA","Hydronephrosis is a common congenital kidney anomaly. While most cases resolve on their own, some require surgery. Clinicians rely on repeated ultrasounds and sometimes invasive tests to decide if surgery is needed, but predicting outcomes is difficult. Researchers at SickKids developed an AI model that analyzes ultrasound images to assist in diagnosing and managing hydronephrosis. This study tests how well the AI integrates into real-world care. Clinicians will first make care decisions without AI and then review the AI's prediction before deciding whether to change their plan. A separate expert, unaware of whether AI influenced the first clinician's plan, will make the final decision to ensure care remains unchanged. The study will assess whether AI improves decision-making, reduces unnecessary tests, and fits into clinical workflows. If successful, the AI model could serve as a complementary tool to make diagnoses more efficient and precise while minimizing invasive procedures.",[42,43],"Hydronephrosis","Hydronephrosis Congenital","NOT_YET_RECRUITING","2026-05-06",{"date":47,"type":48},"2026-05-12","ACTUAL",{"date":50,"type":36},"2026-08-01",{"date":52,"type":36},"2027-01-31",{"name":5,"class":6}]