[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"complications-of-injectable-permanent-synthetic-fillers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:complications-of-injectable-permanent-synthetic-fillers":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":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100659646","natural-history-of-injectable-permanent-synthetic-filler-disease-100659646",false,"NCT07867353","Natural History of Injectable Permanent Synthetic Filler Disease","Prospective Clinical, Magnetic Resonance Imaging, and Histopathologic Characterization of the Natural History of Injectable Permanent Synthetic Filler Disease","Inclusion Criteria:\n\n* Adults with a documented history of injection of permanent synthetic or modeling substances into the gluteal region.\n\nAvailable date or sufficiently reliable estimated date of filler injection to determine disease duration.\n\nProspective clinical assessment documenting local and\u002For systemic manifestations.\n\nAvailable magnetic resonance imaging of the affected anatomical region performed as part of clinical evaluation.\n\nClinically indicated surgical removal of affected tissue. Histopathologic tissue specimen available and of sufficient quality for standardized review.\n\nAvailability of the core clinical, radiologic, and histopathologic variables required for the primary analysis.\n\nWritten informed consent when required by the approved research protocol.\n\nExclusion Criteria:\n\n* Exposure exclusively to temporary or resorbable fillers without evidence of permanent synthetic filler exposure.\n\nInability to determine the approximate date of filler injection. Histopathologic specimens insufficient for standardized evaluation. Magnetic resonance imaging unavailable or technically inadequate for assessment of disease distribution.\n\nIncomplete core clinical data preventing evaluation of the prespecified study outcomes.\n\nPrevious complete surgical removal of the injected material before the index clinical and imaging assessment, when this prevents reconstruction of the untreated disease state.","FEMALE","18 Years",{"count":19,"type":20},450,"ESTIMATED","1 Year","OBSERVATIONAL","Injectable permanent synthetic filler disease is characterized by heterogeneous local and systemic manifestations that may emerge years after filler injection. Although inflammatory reactions, migration, foreign-body granulomas, adipose tissue injury, fat necrosis, and fibrosis have been individually described, the temporal clinicopathologic evolution of the disease remains poorly characterized.\n\nThis prospective observational cohort study aims to characterize the natural history of disease associated with injectable permanent synthetic fillers by integrating time since injection, clinical manifestations, magnetic resonance imaging findings, and histopathologic tissue features. Participants with a history of gluteal injection of permanent synthetic fillers who undergo clinical evaluation, magnetic resonance imaging, and clinically indicated surgical removal of affected tissue will be evaluated. Histopathologic findings will be systematically assessed for adipose tissue injury, acute and chronic inflammation, foreign-body granulomatous reaction, fat necrosis, fibrosis, characteristics of the exogenous material, and vascular or lymphatic involvement.\n\nThe primary objective is to determine how histopathologic disease patterns vary according to time since injection. Secondary objectives include evaluating temporal associations with clinical symptoms, extent of migration on magnetic resonance imaging, fibrosis, granulomatous inflammation, and evidence of superimposed inflammatory reactivation.",[25],"Complications of Injectable Permanent Synthetic Fillers",[27,28,29,30,31],"Injectable permanent synthetic fillers","Biopolymers","Foreign-body granuloma","Chronic inflammation","Iatrogenic allogenosis","RECRUITING","2026-10-05",{"date":35,"type":36},"2026-10-09","ACTUAL",{"date":38,"type":36},"2020-01-22",{"date":40,"type":20},"2026-12-01",{"name":42,"class":43},"Research Inc","INDUSTRY"]