An observational study in Foreign-Body Reaction, Granulomatous Disease and Soft Tissue Necrosis Lower Limb, sponsored by Research Inc. Not yet recruiting at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Research Inc · 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.
Participants will be enrolled before clinically indicated biopsy or filler-removal surgery. Exposure history, symptoms, physical findings, and MRI stage will be recorded using standardized forms. During surgery, samples from mapped tissue planes will be collected without extending the planned excision. Two pathologists blinded to clinical stage will independently grade eight tissue-injury domains and generate a composite severity score. Disagreements will undergo adjudication. The study will evaluate associations between tissue findings, time since injection, and clinical-radiologic stage and will use exploratory clustering to identify histopathologic phenotypes. Because participants are sampled at one operation, the resulting model will be described as a proposed cross-sectional natural-history framework.
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Adults undergoing biopsy or surgical removal of gluteal tissue affected by permanent synthetic filler, spanning early exposure through advanced disease with ulceration or necrosis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age 18 years or older.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Samples will be obtained from predefined superficial, interface, deep, and visibly abnormal regions without extending the clinically indicated excision. Each sample will be oriented and linked to an MRI/operative map.
Procedure: Standardized Tissue Sampling During Clinically Indicated Surgery · Other: Blinded Histopathologic Scoring
Samples will be obtained from predefined superficial, interface, deep, and visibly abnormal regions without extending the clinically indicated excision. Each sample will be oriented and linked to an MRI/operative map. Linked arm/group(s): Prospective Histopathology Cohort.
Two pathologists will independently grade foreign material burden, granulomatous inflammation, fibrosis, fat necrosis, vascular injury, lymphatic involvement, muscle injury, and skin necrosis on 0-to-3 ordinal scales. The proposed composite ranges from 0 to 24; the manual will be locked before the first analytic read. Linked arm/group(s): Prospective Histopathology Cohort.
Composite Histopathologic Severity Score by Clinical-Radiologic Stage
Sum of eight prespecified 0-to-3 domain scores: foreign material burden, granulomatous inflammation, fibrosis, fat necrosis, vascular injury, lymphatic involvement, muscle injury, and skin necrosis. Total score ranges from 0 to 24; higher scores indicate more severe tissue injury.
Time frame: At the index operation and final blinded histopathology assessment of the surgical specimen. 3 months
Prevalence of Individual Histopathologic Features
Proportion of participants with each prespecified feature and distribution of each 0-to-3 domain grade.
Time frame: At final histopathology assessment of the index surgical specimen. 3 months
Histopathologic Phenotype Classification
Data-driven clusters or latent classes based on the eight domains, integrated with clinical and MRI stage to generate a proposed disease-evolution framework.
Time frame: After completion of tissue collection and database lock, using data from the index specimen. 1 year
Plan to share: No — not considered in the informed consent of the patients
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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