[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558660":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":14,"responsibleParty":28,"collaborators":7,"id":30,"slug":7,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":33,"acronym":7,"eligibilityCriteria":34,"healthyVolunteers":31,"sex":35,"minAge":36,"maxAge":7,"enrollmentInfo":37,"targetDuration":40,"studyType":41,"phases":7,"briefSummary":42,"conditions":43,"keywords":7,"overallStatus":16,"whyStopped":7,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":54},{"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,"countryCode":19,"cosmosGeoPoint":20,"geoPoint":25,"contacts":26},"RECRUITING","Humlebæk","Denmark","DK",{"type":21,"coordinates":22},"Point",[23,24],12.5341,55.9618,{"lat":24,"lon":23},[27],{"name":10,"role":11,"phone":7,"phoneExt":7,"email":7},{"type":29,"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":38,"type":39},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.",[44],"Stoma Ileostomy","2025-08-27",{"date":47,"type":48},"2025-09-04","ACTUAL",{"date":50,"type":48},"2024-07-01",{"date":52,"type":39},"2027-07-02",{"name":5,"class":6},1]