[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"granulomatous-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:granulomatous-disease":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100655152","prospective-stage-stratified-histopathologic-study-and-proposed-disease-evolution-model-of-gluteal-permanent-synthetic-filler-complications-100655152",false,"NCT07808970","Prospective Stage-Stratified Histopathologic Study and Proposed Disease-Evolution Model of Gluteal Permanent Synthetic Filler Complications","Inclusion Criteria:\n\nAge 18 years or older.\n\n* Prior gluteal injection of a permanent or unknown nonresorbable filler.\n* Clinically indicated biopsy or surgical excision yielding tissue suitable for histopathologic evaluation.\n* Available history of approximate injection date and standardized preoperative clinical staging.\n* Written consent for tissue analysis and optional future use of deidentified specimens.\n\nExclusion Criteria:\n\n* Specimen composed only of scar or skin without tissue from the filler-affected region.\n* Insufficient tissue quality for routine histology.\n* Acute bacterial infection that precludes distinction of the underlying chronic tissue response unless infection is itself a prespecified advanced-stage feature.\n* Prior oncologic radiation to the sampled gluteal region.\n* Declined consent for research use of surgical tissue.","ALL","18 Years",{"count":18,"type":19},200,"ESTIMATED","1 Year","OBSERVATIONAL","This prospective biospecimen cohort will collect and analyze tissue from adults undergoing clinically indicated surgery for gluteal permanent synthetic filler disease. Two blinded pathologists will score foreign material burden, inflammation, fibrosis, necrosis, vascular and lymphatic injury, and deep-tissue involvement. Histopathologic severity will be compared across clinical-radiologic stages and time since injection. The study will propose a cross-sectional disease-evolution framework and assess the reproducibility of the scoring system.",[24,25,26,27],"Foreign-Body Reaction","Granulomatous Disease","Soft Tissue Necrosis Lower Limb","Gluteal Permanent Synthetic Filler Disease",[29,30,31,32,33,34,35],"Biopolymers","Histopathology","Foreign-Body Granuloma","Fibrosis","Fat Necrosis","Disease Staging","Natural History","NOT_YET_RECRUITING","2026-09-07",{"date":39,"type":40},"2026-09-09","ACTUAL",{"date":42,"type":19},"2026-10-01",{"date":44,"type":19},"2027-12-01",{"name":46,"class":47},"Research Inc","INDUSTRY"]