[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572892":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":35,"centralContacts":40,"locations":50,"responsibleParty":67,"collaborators":28,"id":69,"slug":28,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":28,"enrollmentInfo":78,"targetDuration":28,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":53,"whyStopped":28,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Salts Healthcare","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Confidence Be 1-Piece Closed Bag","ACTIVE_COMPARATOR","The reference device is CE Marked and already commercially available",[13],"Device: Confidence Be 1-Piece Closed Bag",{"label":15,"type":10,"description":11,"interventionNames":16},"Confidence Natural 1-Piece Closed Bag",[17],"Device: Confidence Natural 1-Piece Closed Bag",{"label":19,"type":10,"description":20,"interventionNames":21},"Confidence Be go 1-Piece Closed Bag","The reference device is CE Marked and already commercially available in Australia",[22],"Device: Confidence Be go 1-Piece Closed Bag",[24,29,32],{"type":25,"name":9,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Active Chamber Filter - Circle Shape",[9],null,{"type":25,"name":15,"description":30,"armGroupLabels":31,"otherNames":28},"Protective Filter - Circle Shape",[15],{"type":25,"name":19,"description":33,"armGroupLabels":34,"otherNames":28},"Active Chamber Filter - Hexagon Shape",[19],[36],{"name":37,"affiliation":38,"role":39},"Mireille Hamson","Salt Healthcare","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":28,"email":45},"Clinical Research Coordinator","CONTACT","+44 (0) 121 333 2015","info@cssinstitute.co.uk",{"name":47,"role":43,"phone":48,"phoneExt":28,"email":49},"Clinical Research Nurse","07917630767","sarah.ashworth@salts.co.uk",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Central Skin Sciences Institute (CSSI) Salts Healthcare","RECRUITING","Birmingham","England","B7 4AA","United Kingdom","UK",{"type":60,"coordinates":61},"Point",[62,63],-1.89983,52.48142,{"lat":63,"lon":62},[66],{"name":37,"role":43,"phone":28,"phoneExt":28,"email":28},{"type":68,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100572892",false,"NCT06739174","Assessment of Colostomy Bags with an Active Chamber Filter System and Incidence of Filter-Related Complication","Three Way Crossover Study: Assessment of Colostomy Bags with an Active Chamber Filter System and Incidence of Filter-Related Complication by People Living with a Colostomy","BREEZE-01","Inclusion Criteria:\n\n* Adult aged over 18 years\n* Colostomy for 6 months or longer\n* Experiences any filter-related complications, such as ballooning, pancaking, odour, or faecal leakage through the filter, at least once a week (7 days)\n* Independent in colostomy care\n* Using a flat, closed colostomy bag\n* Stoma size (diameter) less than 55 mm\n* Using a colostomy bag with a hydrocolloid wafer (baseplate)\n* Able to read and complete the study questionnaire in English\n\nExclusion Criteria:\n\n* Uses colostomy irrigation\n* Bleeding or broken peristomal skin\n* Receiving or had radiotherapy or chemotherapy in the last 2 months\n* Pregnant or breastfeeding\n* Taking part in another clinical study\n* Currently receiving treatment under the care of a stoma clinical nurse specialist","ALL","18 Years",{"count":79,"type":80},27,"ESTIMATED","INTERVENTIONAL",[83],"NA","This 3-way crossover study aims to evaluate whether colostomy bags with an active chamber filter system reduce the incidence of filter-related complications, such as ballooning and pancaking, help neutralise odour, and minimise faecal leakage through the filter compared to colostomy bags with a protective filter",[86,87],"Colostomy - Stoma","Colostomy Complications",[89,90,91,92,93],"Colostomy bags","Colostomy","Ballooning","Pancaking","Colostomy bag filter-related complications","2024-12-12",{"date":96,"type":97},"2024-12-18","ACTUAL",{"date":99,"type":97},"2024-11-29",{"date":101,"type":80},"2025-04-30",{"name":5,"class":6},1]