[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gluteal-permanent-synthetic-filler-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gluteal-permanent-synthetic-filler-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"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":48},"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",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":55,"targetDuration":56,"studyType":21,"phases":4,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100654981","prospective-paired-evaluation-of-conventional-versus-structured-magnetic-resonance-imaging-interpretation-for-preoperative-assessment-of-gluteal-permanent-synthetic-filler-disease-100654981","NCT07808463","Prospective Paired Evaluation of Conventional Versus Structured Magnetic Resonance Imaging Interpretation for Preoperative Assessment of Gluteal Permanent Synthetic Filler Disease","Inclusion Criteria:\n\n* Age 18 years or older.\n* History of gluteal injection with a permanent or unknown nonresorbable filler.\n* Preoperative pelvic\u002Fgluteal MRI performed using the study acquisition protocol.\n* Planned surgical removal, biopsy, or operative exploration within 90 days after MRI.\n* Written informed consent for paired image interpretation and use of operative findings.\n\nExclusion Criteria:\n\n* MRI contraindication or nondiagnostic imaging caused by motion or incomplete anatomic coverage.\n* Prior extensive gluteal filler removal that prevents mapping of the predefined compartments.\n* No operative procedure within 90 days after MRI and therefore no reference-standard assessment.\n* Acute life-threatening infection or emergency surgery that prevents completion of the preoperative reporting sequence.\n* Inability to provide consent.",{"count":18,"type":19},"1 Day","This prospective paired diagnostic-impact study will compare conventional qualitative MRI reporting with a new structured anatomic classification in adults undergoing surgery for gluteal permanent synthetic filler disease. The structured report will document material effects across superficial, deep, muscular, regional, lymphatic, and interstitial compartments. Standardized intraoperative mapping will serve as the reference standard. The main outcome is the difference in sensitivity for surgically confirmed compartment involvement",[24,59,27],"Soft Tissue Filler Complication",[29,61,62,63,64,65],"Permanent Synthetic Fillers","Magnetic Resonance Imaging","Structured Reporting","Preoperative Planning","Gluteal Region",{"date":67,"type":40},"2026-09-08",{"date":42,"type":19},{"date":70,"type":19},"2026-12-31",{"name":46,"class":47}]