[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549320":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":27,"locations":35,"responsibleParty":58,"collaborators":60,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":19,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":19,"enrollmentInfo":72,"targetDuration":19,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":84,"overallStatus":37,"whyStopped":19,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Royal North Shore Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Gynaecological HDR brachytherapy patients","EXPERIMENTAL","Using 3D-printed custom applicators to treat gynaecological HDR brachytherapy patients",[13],"Device: 3D-printed custom applicator",[15],{"type":16,"name":17,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","3D-printed custom applicator",[9],null,[21,24],{"name":22,"affiliation":5,"role":23},"Marita Morgia, MD","PRINCIPAL_INVESTIGATOR",{"name":25,"affiliation":5,"role":26},"Jeremy Booth, PhD QMP","STUDY_DIRECTOR",[28,32],{"name":22,"role":29,"phone":30,"phoneExt":19,"email":31},"CONTACT","9463 1300","Marita.Morgia@health.nsw.gov.au",{"name":25,"role":29,"phone":33,"phoneExt":19,"email":34},"94631300","jeremy.booth@health.nsw.gov.au",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","St Leonards","New South Wales","2067","Australia","AU",{"type":44,"coordinates":45},"Point",[46,47],151.19836,-33.82344,{"lat":47,"lon":46},[50,54],{"name":51,"role":29,"phone":52,"phoneExt":19,"email":53},"Carol Kwong","02 9463 1339","Carolyn.Kwong@health.nsw.gov.au",{"name":55,"role":29,"phone":56,"phoneExt":19,"email":57},"Heidi Tsang","02 9463 1340","Heidi.Tsang@health.nsw.gov.au",{"type":59,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[61],{"name":62,"class":6},"Northern Sydney and Central Coast Area Health Service","100549320","3d-printed-custom-applicators-for-hdr-bt-disco-100549320",false,"NCT06432478","3D Printed Custom Applicators for HDR BT (DISCO)","Study of 3D-printed Custom Applicators for Intracavitary HDR Gynaecological Brachytherapy (DISCO)","Inclusion Criteria:\n\n* Able to give informed consent\n* Patients indicated for intracavitary brachytherapy\n* FIGO stage I-IVA\n* ECOG 0-2\n* Primary endometrial cancer, primary vaginal cancer, primary vulva cancer, recurrent gynaecological cancer\n\nExclusion Criteria:\n\n* Pregnancy\n* Patients contraindicated for brachytherapy\n* Inflammatory bowel disease\u002Fhistory of adhesions\u002Fbowel obstruction\n* Renal transplant\u002Fhorseshoe kidney\n* Patients with significant LVSI or pelvic sidewall invasion\n* Patients requiring interstitial brachytherapy implants","FEMALE","18 Years",{"count":73,"type":74},10,"ESTIMATED","INTERVENTIONAL",[77],"NA","Intracavitary brachytherapy for gynaecological cancer currently use cylinder-type applicators or custom wax moulds to place a radioactive source in close proximity to the treatment area and provide highly conformal dose distributions. This study is a Phase IIa non-randomised interventional pilot trial that will investigate the feasibility of successfully treating patients with 3D-printed custom applicators.",[80,81,82,83],"Gynecologic Cancer","Endometrial Cancer","Vaginal Cancer","Vulva Cancer",[85,86,87],"3D-printed applicator","Gynaecological Cancer","Brachytherapy","2026-02-04",{"date":90,"type":91},"2026-02-06","ACTUAL",{"date":93,"type":91},"2023-11-24",{"date":95,"type":74},"2028-09",{"name":5,"class":6},1]