[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584166":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":24,"locations":23,"responsibleParty":30,"collaborators":23,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":38,"acronym":23,"eligibilityCriteria":39,"healthyVolunteers":36,"sex":40,"minAge":23,"maxAge":41,"enrollmentInfo":42,"targetDuration":23,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":23,"overallStatus":52,"whyStopped":23,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":23},{"fullName":5,"class":6},"East Tennessee Children's Hospital","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Standard first, anatomic second","Patients are started with the standard nasal conformer for the first 3 months and then switched to the anatomic conformer for the second 3 months",[12],"Device: use of an anatomically designed nasal conformer",{"label":14,"type":6,"description":15,"interventionNames":16},"Anatomic first, standard second","Patients are started with the anatomic nasal conformer for the first 3 months and then switched to the standard conformer for the second 3 months",[12],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","use of an anatomically designed nasal conformer","this study will evaluate the use of a nasal conformer that has been designed to match the internal airway anatomy of the anterior nose rather than the standard hollow, conical conformer currently available on the market",[14,9],null,[25],{"name":26,"role":27,"phone":28,"phoneExt":23,"email":29},"Justin Daggett, MD","CONTACT","18658244939","jrdaggett@etch.com",{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Justin Daggett","Principal Investigator","100584166","phase-2-evaluation-of-a-novel-nasal-conformer-in-pediatric-patients-100584166",false,"NCT06885801","Evaluation of a Novel Nasal Conformer in Pediatric Patients","Inclusion Criteria:\n\n* Patient's undergoing primary cleft lip repair or release of nasal scarring\n\nExclusion Criteria:\n\n* patient or parents declined participation postoperative nasal stenting is judged clinically inappropriate","ALL","18 Years",{"count":43,"type":44},20,"ESTIMATED","INTERVENTIONAL",[47],"PHASE2","This study compares the current commercially available nasal conformer available for use in cleft lip repair and nasal scar release to a novel, anatomically shaped conformer based upon typical nasal airspace shape. This will follow patients using both of these types of splints during the post-operative healing process with one group starting with the standard splint and then moving to the anatomic conformer and the second group beginning with the anatomic and them moving to the standard conformer. This study will evaluate the patient experience and outcomes of the 2 types of conformers, looking at the discomfort, device dislodgements, ease of use and occurrence of complications such as skin irritation and rashes or skin breakdown.",[50,51],"Cleft Lip","Nasal Surgical Procedures","NOT_YET_RECRUITING","2025-03-13",{"date":55,"type":56},"2025-03-20","ACTUAL",{"date":58,"type":44},"2025-06-01",{"date":60,"type":44},"2030-12-01",{"name":5,"class":6}]