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Prospective Stage-Stratified Histopathologic Study and Proposed Disease-Evolution Model of Gluteal Permanent Synthetic Filler Complications

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07808970
Lead Sponsor Research Inc
Conditions
(from sponsor)		 Foreign-Body Reaction, Granulomatous Disease, Soft Tissue Necrosis Lower Limb, Gluteal Permanent Synthetic Filler Disease
Related terms Fat Necrosis, Fibrosis, Foreign-Body Reaction, Granuloma, Foreign-Body
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov