[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558660":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":14,"responsibleParty":27,"collaborators":7,"id":29,"slug":7,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":32,"acronym":7,"eligibilityCriteria":33,"healthyVolunteers":30,"sex":34,"minAge":35,"maxAge":7,"enrollmentInfo":36,"targetDuration":39,"studyType":40,"phases":7,"briefSummary":41,"conditions":42,"keywords":7,"overallStatus":16,"whyStopped":7,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":53},{"fullName":5,"class":6},"Coloplast A\u002FS","INDUSTRY",null,[9],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},"Thomas Krarup Simonsen","CONTACT","+4549111873","dktksi@coloplast.com",[15],{"facility":5,"status":16,"city":17,"state":7,"zip":7,"country":18,"cosmosGeoPoint":19,"geoPoint":24,"contacts":25},"RECRUITING","Humlebæk","Denmark",{"type":20,"coordinates":21},"Point",[22,23],12.5341,55.9618,{"lat":23,"lon":22},[26],{"name":10,"role":11,"phone":7,"phoneExt":7,"email":7},{"type":28,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100558660",false,"NCT06554015","Prospective Longitudinal Study of Heylo™ for People Living With a Stoma","Inclusion Criteria:\n\n1. Are you at least 18 years old? \\[Yes\u002FNo\\]\n2. Do you have an ileostomy or a colostomy? \\[Yes\u002FNo\\]\n3. Have you used Heylo™ for less than seven days? \\[Yes\u002FNo\\]\n\nExclusion Criteria:\n\n1\\) Do you have a stoma reversal planned (surgery date within the next 6 months)? Yes\u002FNo\\]","ALL","18 Years",{"count":37,"type":38},100,"ESTIMATED","1 Year","OBSERVATIONAL","This study aims to longitudinally evaluate the usage and long-term benefits of the CE-marked device, Heylo™, a digital leakage notification system for people with intestinal stomas. The system, which includes a smartphone application, an adhesive sensor layer, and a Bluetooth transmitter, notifies users of changes in their baseplate status, potentially reducing stoma effluent leakage and improving quality of life. The physical Heylo™ device, is part of the Coloplast Charter telehealth service.",[43],"Stoma Ileostomy","2025-08-27",{"date":46,"type":47},"2025-09-04","ACTUAL",{"date":49,"type":47},"2024-07-01",{"date":51,"type":38},"2027-07-02",{"name":5,"class":6},1]