[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659646":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":33,"studyPopulation":34,"armGroups":35,"interventions":29,"overallOfficials":29,"centralContacts":39,"locations":45,"responsibleParty":61,"collaborators":29,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":29,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":29,"enrollmentInfo":74,"targetDuration":77,"studyType":78,"phases":29,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":48,"whyStopped":29,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Research Inc","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Temporal Pattern of Histopathologic Tissue Injury","Predefined histopathologic features will be assessed according to the time elapsed since filler injection. Features will include adipose tissue injury, acute inflammatory activity, chronic inflammation, foreign-body giant-cell and granulomatous reaction, fat necrosis, and fibrosis. The primary analysis will evaluate the association between disease duration, modeled primarily as a continuous variable, and the distribution and severity of these histopathologic findings.","At surgical tissue sampling; disease duration measured from filler injection to surgical tissue collection. 1 week",[14,18,22,25],{"measure":15,"description":16,"timeFrame":17},"Clinical Symptom Burden According to Disease Duration","Local and systemic symptoms documented during prospective clinical assessment will be characterized according to time since filler injection. Individual symptoms and overall symptom burden will be evaluated.","1 year",{"measure":19,"description":20,"timeFrame":21},"Foreign-Body Granulomatous Inflammation","The presence and severity of histiocytic inflammation, multinucleated foreign-body giant cells, and granulomatous reaction will be evaluated histopathologically and analyzed in relation to disease duration.","At surgical tissue sampling. 1 week",{"measure":23,"description":24,"timeFrame":21},"Severity and Pattern of Fibrosis","Fibrosis will be assessed according to severity and morphologic distribution, including diffuse, perivacuolar, or capsular patterns when identifiable. Features of mature, hyalinized, fragmented, or disrupted fibrosis will also be recorded.",{"measure":26,"description":27,"timeFrame":28},"Histopathologic Evidence of Superimposed Inflammatory Reactivation","The coexistence of mature or longstanding fibrosis with superimposed acute inflammatory activity will be evaluated. The association between disrupted or fragmented fibrotic compartments and acute inflammatory findings will be assessed as a potential morphologic correlate of inflammatory reactivation.","At surgical tissue sampling; 1 week",null,{"allocation":29,"interventionModel":29,"interventionModelDescription":29,"primaryPurpose":29,"observationalModel":31,"timePerspective":32,"maskingInfo":29},"COHORT","PROSPECTIVE","Permanent synthetic filler disease represents a heterogeneous clinicopathologic condition associated with the injection of persistent exogenous materials for body contouring. Individual manifestations including adipose tissue injury, chronic inflammation, foreign-body granuloma formation, fibrosis, and local or regional migration have been described; however, the relationship between these findings and the duration of disease has not been systematically characterized.\n\nThe present study was designed as a prospective observational cohort to investigate the clinicopathologic evolution of permanent synthetic filler disease. The central exposure variable is the interval between filler injection and surgical tissue sampling, expressed in years. Clinical manifestations, magnetic resonance imaging findings, and histopathologic characteristics will be integrated to determine whether reproducible disease states are associated with increasing time since injection.\n\nHistopathologic evaluation will assess predefined features within the adipose, inflammatory, granulomatous, fibrotic, vascular, and lymphatic compartments. Adipose tissue findings will include adipocyte size heterogeneity, vacuolization, fragmentation, fat necrosis, lipophagic reaction, and disruption of lobular architecture. Inflammatory findings will include acute inflammatory activity, chronic histiocytic and lymphoplasmacytic inflammation, multinucleated foreign-body giant cells, and granuloma formation. Fibrotic findings will include the extent and pattern of fibrosis, capsular organization, hyalinization, and structural disruption or fragmentation. The distribution and morphology of exogenous material, including intracellular, extracellular, vacuolar, and collagen-associated patterns, will also be documented when identifiable.\n\nMagnetic resonance imaging will be used to characterize the presence and anatomical extent of filler migration. Clinical data will include local and systemic manifestations documented prospectively during patient evaluation.\n\nDisease duration will initially be analyzed as a continuous variable. Nonlinear temporal relationships between disease duration and selected clinical, radiologic, and histopathologic outcomes may be assessed using flexible regression methods. The study will also evaluate whether mature or disrupted fibrotic compartments are associated with superimposed acute inflammatory activity, as a potential morphologic correlate of inflammatory reactivation in longstanding disease.","The study population consists of consecutive adult patients evaluated at a tertiary referral center for complications associated with prior gluteal injection of permanent synthetic fillers. Participants undergo prospective clinical evaluation and magnetic resonance imaging as part of their clinical assessment and subsequently undergo clinically indicated surgical removal of affected tissue, allowing histopathologic characterization of the disease.",[36],{"label":37,"type":29,"description":38,"interventionNames":29},"Injectable Permanent Synthetic Filler Disease Cohort","Consecutive participants with a documented history of gluteal injection of permanent synthetic fillers who undergo prospective clinical assessment, magnetic resonance imaging, and clinically indicated surgical removal of affected tissue with subsequent histopathologic evaluation. Participants are not assigned to an intervention by the investigators.",[40],{"name":41,"role":42,"phone":43,"phoneExt":29,"email":44},"Edison Osorio, MD, Plastic surgeon","CONTACT","+573226140611","info@edisonosorio.com",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":29,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Clinica Bioforma","RECRUITING","Medellín","Antioquia","Colombia","CO",{"type":54,"coordinates":55},"Point",[56,57],-75.57151,6.245,{"lat":57,"lon":56},[60],{"name":41,"role":42,"phone":43,"phoneExt":29,"email":44},{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Brian Ramirez, MD, MSc","MD, Aerospace medicine, MSc, PhD(c)","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":75,"type":76},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.",[81],"Complications of Injectable Permanent Synthetic Fillers",[83,84,85,86,87],"Injectable permanent synthetic fillers","Biopolymers","Foreign-body granuloma","Chronic inflammation","Iatrogenic allogenosis","2026-10-05",{"date":90,"type":91},"2026-10-09","ACTUAL",{"date":93,"type":91},"2020-01-22",{"date":95,"type":76},"2026-12-01",{"name":5,"class":6},1]