[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634976":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":12,"locations":21,"responsibleParty":38,"collaborators":7,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":7,"eligibilityCriteria":45,"healthyVolunteers":42,"sex":46,"minAge":47,"maxAge":7,"enrollmentInfo":48,"targetDuration":51,"studyType":52,"phases":7,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":24,"whyStopped":7,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},{"fullName":5,"class":6},"Medtronic","INDUSTRY",null,[9],{"type":10,"name":11,"description":11,"armGroupLabels":7,"otherNames":7},"OTHER","None, observational standard of care study",[13,18],{"name":14,"role":15,"phone":16,"phoneExt":7,"email":17},"Katherine Schiller","CONTACT","763-526-8329","katherine.schiller@medtronic.com",{"name":19,"role":15,"phone":7,"phoneExt":7,"email":20},"Amita Patel","amita.patel@medtronic.com",[22],{"facility":23,"status":24,"city":25,"state":7,"zip":7,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Japanese Red Cross Asahikawa Hospital","RECRUITING","Asahikawa","Japan","JP",{"type":29,"coordinates":30},"Point",[31,32],142.36489,43.77063,{"lat":32,"lon":31},[35],{"name":36,"role":15,"phone":7,"phoneExt":7,"email":37},"Kosuke Takabayashi, Dr.","kosuketakabayashi@gmail.com",{"type":39,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100634976","propel-drug-eluting-sinus-implant-family-ibuki-cohort-100634976",false,"NCT07546682","Propel Drug-Eluting Sinus Implant Family IBUKI Cohort","Inclusion Criteria:\n\n* Patient or legally authorized representative (LAR) provides authorization and\u002For consent per institution and geographical requirements\n\n  * Patient has, or is intended to receive or be treated with, an eligible Medtronic product\n  * Patient is consented within the enrollment window of the therapy received, as applicable\n  * Patient has a confirmed diagnosis of CRS, and is indicated for FESS per Japan standard practice\n  * FESS is successfully completed without the occurrence of major\u002Fsignificant complications that may confound study results\n  * Successful placement of 2 to 4 corticosteroid-eluting implants in the ethmoid or frontal sinus (1 implant per sinus) in accordance with implant IFUs\n  * NOVAPAK is the only hemostatic packing material placed bilaterally in ethmoid sinuses\n\nExclusion Criteria:\n\n* Patient has clinical evidence of disease or a condition expected to compromise survival or ability to complete follow-up assessments through Month 6 (end of study)\n\n  * Participation is excluded by local law\n  * Patient is currently enrolled in, or plans to enroll in, any concurrent study that may confound the PSR results (i.e., no required intervention that could affect interpretation of all-around product safety and\u002For effectiveness)\n  * Patient has received biologic medication approved for the treatment of CRSwNP (e.g., dupilumab, mepolizumab) in ≤ 12 weeks prior to the baseline\u002Fprocedure visit\n  * Patient is contraindicated in accordance with IFUs of PROPEL family implants and\u002For NOVAPAK","ALL","18 Years",{"count":49,"type":50},100,"ESTIMATED","6 Months","OBSERVATIONAL","To confirm clinical safety and performance for the PROPEL family of products when used according to IFUs and standard of care in Japan.",[55],"Chronic Rhinosinusitis (CRS)",[57],"Chronic Rhinosinusitis, corticosteroid-eluting sinus implants, 22- item sinonasal outcome test","2026-04-16",{"date":60,"type":61},"2026-04-23","ACTUAL",{"date":63,"type":50},"2026-04",{"date":65,"type":50},"2027-08",{"name":5,"class":6},1]