[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539917":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":49,"collaborators":51,"id":54,"slug":20,"hasResults":55,"nctId":56,"briefTitle":17,"officialTitle":17,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":20,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Carilion Clinic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Receiving 3D Personalized Ostomy Appliance","EXPERIMENTAL","The personalized ostomy appliances are designed based off of a 3D scan. We will scan your ostomy to create a 3D picture in the computer system that is an exact copy of your ostomy using plastic. We then apply computer aided design (CAD) tools to modify your normal ostomy baseplates.",[13],"Device: 3D Printed Personalized Ostomy Appliance",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","3D Printed Personalized Ostomy Appliance","Study procedures will include getting your stoma scanned, receiving personalized ostomy appliances in the mail, receiving a personalized ostomy template, which will be printed using a 3D printer, in the mail, and completing a daily symptom diary along with a weekly survey for 4 weeks.3D printing is done using a machine that takes the 3D image from the computer and prints a replica of the image using plastic or other materials.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Farrell Adkins, MD","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Adam Goode, MD","CONTACT","540-224-5170","aegoode@carilionclinic.org",{"name":32,"role":28,"phone":20,"phoneExt":20,"email":33},"Uma Kelavkar","ukelavkar@carilionclinic.org",[35],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Roanoke","Virginia","24013","United States",{"type":42,"coordinates":43},"Point",[44,45],-79.94143,37.27097,{"lat":45,"lon":44},[48],{"name":27,"role":28,"phone":20,"phoneExt":20,"email":30},{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[52],{"name":53,"class":6},"Virginia Polytechnic Institute and State University","100539917",false,"NCT06310070","3DPPOA","Inclusion Criteria:\n\n* 18-100 years old\n* Must have had current ostomy appliance for \\> 6 weeks - if patients with stomas less than 6 weeks are included, their personalized templates will not be useful once the stoma size has changed after their initial scan.\n* Must have experienced \\> 1 leakage in the week leading up to day of consent. - If patients are not experiencing leakages, then there will be no baseline data to compare effectiveness of the post-3D appliance intervention.\n* Participants must be able to consent for themselves\n* Access to phone AND computer with internet access. Patient must be able to provide electronic mailing address for e-consent documentation and REDCap surveys.\n\nExclusion Criteria:\n\n* Concern for patient being able to be reached over the phone or reliable internet access for REDCap survey completion\n* Existing peri-stomal skin breakdown including ulceration or mucocutaneous separation.\n* Diagnosis of infection around the peristomal region. (erythema is NOT an exclusion criteria)",true,"ALL","18 Years","100 Years",{"count":64,"type":65},30,"ESTIMATED","INTERVENTIONAL",[68],"NA","The goal of this clinical trial is to learn about the effectiveness of using a 3D scan for a personal ostomy appliance. The main question it aims to answer is:\n\n• Whether or not a 3D scan of a stoma reduces leakages and improves patient quality of life in regard to using a personalized ostomy appliance.\n\nParticipants will\n\n* Spend 2 weeks with their standard of care ostomy appliance\n* Spend 2 weeks with their personalized ostomy appliance made from a 3D scan\n* Participate in daily surveys and weekly quality of life surveys conducted over the phone",[71,72,73],"3D Printing","Ostomy","Leakage","2025-01-20",{"date":76,"type":77},"2025-01-22","ACTUAL",{"date":79,"type":77},"2024-05-10",{"date":81,"type":65},"2025-06-05",{"name":5,"class":6},1]