[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632917":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":48,"collaborators":18,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Friedrich-Alexander-Universität Erlangen-Nürnberg","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SNM-guided implantation","ACTIVE_COMPARATOR","Surgical implantation of sacral neuromodulation after generation of digital twin and intraoperative efficacy testing",[13],"Procedure: SNM\u002FMRI\u002FEMG",{"label":15,"type":16,"description":17,"interventionNames":18},"SNM","NO_INTERVENTION","SNM implantation based on general knowledge and adult measurements",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","SNM\u002FMRI\u002FEMG","Participants are receiving clinical baseline evaluation, preoperative sacral and functional MRI, reconstruction of digital twin, surgical implantation of sacral neuromodulation including intraoperative testing, postoperative sacral and functional MRI, and clinical follow-up",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Sonja Diez, PD Dr. med.","CONTACT","09131 - 85 32923","sonja.diez@uk-erlangen.de",[32],{"facility":33,"status":34,"city":35,"state":18,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Pediatric Surgery in the Children's Hospital","RECRUITING","Erlangen","91054","Germany","DE",{"type":40,"coordinates":41},"Point",[42,43],11.00783,49.59099,{"lat":43,"lon":42},[46],{"name":27,"role":28,"phone":47,"phoneExt":18,"email":30},"0049 9131 8532923",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Dr. med. Sonja Diez","Managing senior physician of Pediatric Surgery, University Hospital Erlangen, and PI of SMART-GUT","100632917","improvement-of-understanding-of-pediatric-sacral-neuromodulation-therapeutic-strategies-and-outcome-variables-100632917",false,"NCT07519915","Improvement of Understanding of Pediatric Sacral Neuromodulation: Therapeutic Strategies and Outcome Variables","Stimulation Modeling and Adaptive Response Tracking in Pediatric Gastrointestinal Motility Disorders","SMART-GUT","Inclusion Criteria:\n\n* informed consent of patient and care taker\n* gastrointestinal motility disorder, disregarding underlying diseases\n* exclusion of mechanical obstructions in the gastrointestinal passage\n* age between 3 and 18\n\nExclusion Criteria:\n\n* pregnancy\u002Fbreast feeding\n* decreased renal or thyroidal function\n* drug intake of Beta-blockers, antispasmodics, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin\n* contradictions for MRI\n* indication for analgosedation for MRI\n* inflammatory bowel diseases\n* fractures\u002Fdifferent anatomy in sacral region\n* epilepsy\n* presence of cardiac pacemakers","ALL","3 Years","18 Years",{"count":64,"type":65},25,"ESTIMATED","INTERVENTIONAL",[68],"NA","The goal of this study is to learn about the effects of sacral neuromodulation in pediatric patients with gastrointestinal motility disorders. By combining advanced neuroimaging, patient-specific biophysical modeling, electrophysiological characterization, and clinical translation, the SMART-GUT project establishes a comprehensive framework to systematically investigate neuromodulation in this pediatric population. This integrative approach enables a direct link between mechanism, targeting, and clinical outcome.",[71,72,73],"Gastrointestinal Motility Disorders in Children","Hirschsprung Disease","Constipation - Functional",[75,76,77,78],"pediatric gastrointestinal motility disorders","chronic constipation","Hirschsprung disease","sacral neuromodulation","2026-04-06",{"date":81,"type":82},"2026-04-09","ACTUAL",{"date":84,"type":82},"2018-07-01",{"date":86,"type":65},"2029-12-31",{"name":5,"class":6},1]