Foreign-Body ReactionNCT07808970
Prospective Stage-Stratified Histopathologic Study and Proposed Disease-Evolution Model of Gluteal Permanent Synthetic Filler Complications
An observational study of Foreign-Body Reaction and Granulomatous Disease, run by Research Inc at 1 site in Colombia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foreign-Body Reaction, Granulomatous Disease, Soft Tissue Necrosis Lower Limb
- What is being tested?
- Standardized Tissue Sampling During Clinically Indicated Surgery and Blinded Histopathologic Scoring
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteColombia
- Study dates
- 1 Oct 2026to 1 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing biopsy or surgical removal of gluteal tissue affected by permanent synthetic filler, spanning early exposure through advanced disease with ulceration or necrosis.
Who may be able to join
- Age 18 years or older.
- Prior gluteal injection of a permanent or unknown nonresorbable filler.
- Clinically indicated biopsy or surgical excision yielding tissue suitable for histopathologic evaluation.
- Available history of approximate injection date and standardized preoperative clinical staging.
- Written consent for tissue analysis and optional future use of deidentified specimens.
Who cannot join
- Specimen composed only of scar or skin without tissue from the filler-affected region.
- Insufficient tissue quality for routine histology.
- Acute bacterial infection that precludes distinction of the underlying chronic tissue response unless infection is itself a prespecified advanced-stage feature.
- Prior oncologic radiation to the sampled gluteal region.
- Declined consent for research use of surgical tissue.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site
Clinica Bioforma
Medellín, Antioquia
Edison Osorio, MD, Plastic surgeon, +573226140611, info@edisonosorio.com
About this study
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.
Read the detailed description
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.
- Conditions
- Foreign-Body Reaction, Granulomatous Disease, Soft Tissue Necrosis Lower Limb, Gluteal Permanent Synthetic Filler Disease
- Being tested
- Standardized Tissue Sampling During Clinically Indicated Surgery, Blinded Histopathologic Scoring
- Keywords
- Biopolymers, Histopathology, Foreign-Body Granuloma, Fibrosis, Fat Necrosis, Disease Staging, Natural History
- Medical subject headings
- Foreign-Body Reaction, Granuloma, Foreign-Body, Fibrosis, Fat Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Tissue Sampling During Clinically Indicated SurgeryProcedure or surgery
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.
Blinded Histopathologic ScoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Histopathology Cohort | 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. Receives: Procedure: Standardized Tissue Sampling During Clinically Indicated Surgery; Other: Blinded Histopathologic Scoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the index operation and final blinded histopathology assessment of the surgical specimen. 3 months
Secondary outcomes (1)
Prevalence of Individual Histopathologic Features
Proportion of participants with each prespecified feature and distribution of each 0-to-3 domain grade.
Measured: At final histopathology assessment of the index surgical specimen. 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Foreign-Body ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edison Osorio, MD, plastic surgery, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808970
- Sponsor's protocol ID
- 009
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not considered in the informed consent of the patients
Publications
Pachon Suarez JE, Tello VZR, Cifuentes RCR, Cuadros AMP, Salazar MC. Biopolymers: Histopathologic Case Series of Patients with Permanent Synthetic Fillers Presenting Chronic Granulomatous Reaction and Hypercalcemia. Plast Reconstr Surg Glob Open. 2024 Oct 15;12(10):e6159. doi: 10.1097/GOX.0000000000006159. eCollection 2024 Oct.
PubMed 39410973Pachon Suarez JE, Salazar MC, Rizo VZ. Classification for Staging and Managing Patients with Biopolymer-induced Human Adjuvant Disease. Plast Reconstr Surg Glob Open. 2022 Feb 24;10(2):e4137. doi: 10.1097/GOX.0000000000004137. eCollection 2022 Feb.
PubMed 35233337Xu T, Zhang J, Zhu Y, Zhao W, Pan C, Ma H, Zhang L. A poly(hydroxyethyl methacrylate)-Ag nanoparticle porous hydrogel for simultaneous in vivo prevention of the foreign-body reaction and bacterial infection. Nanotechnology. 2018 Sep 28;29(39):395101. doi: 10.1088/1361-6528/aad257. Epub 2018 Jul 10.
PubMed 29989569Osorio E, Ramirez B, Herrera O, Suarez C, Ciro C, Varela A. Three-flap Technique: Comprehensive Approach for Biopolymer Removal in the Gluteal and Lumbar Regions. Plast Reconstr Surg Glob Open. 2026 Jul 23;14(7):e7870. doi: 10.1097/GOX.0000000000007870. eCollection 2026 Jul.
PubMed 42495057
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Stage-Stratified Histopathologic Study and Proposed Disease-Evolution Model of Gluteal Permanent Synthetic Filler Complications
- ClinicalTrials.gov ID
- NCT07808970
- Acronym / sponsor ID
- 009
- Conditions
- Foreign-Body Reaction, Granulomatous Disease, Soft Tissue Necrosis Lower Limb, Gluteal Permanent Synthetic Filler Disease
- Keywords
- Biopolymers, Histopathology, Foreign-Body Granuloma, Fibrosis, Fat Necrosis, Disease Staging, Natural History
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Research IncIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Histopathology Cohort | – | Procedure: Standardized Tissue Sampling During Clinically Indicated Surgery, Other: Blinded Histopathologic ScoringSamples 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing biopsy or surgical removal of gluteal tissue affected by permanent synthetic filler, spanning early exposure through advanced disease with ulceration or necrosis.
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Prior gluteal injection of a permanent or unknown nonresorbable filler.
- Clinically indicated biopsy or surgical excision yielding tissue suitable for histopathologic evaluation.
- Available history of approximate injection date and standardized preoperative clinical staging.
- Written consent for tissue analysis and optional future use of deidentified specimens.
Key exclusion criteria (5 listed)
- Specimen composed only of scar or skin without tissue from the filler-affected region.
- Insufficient tissue quality for routine histology.
- Acute bacterial infection that precludes distinction of the underlying chronic tissue response unless infection is itself a prespecified advanced-stage feature.
- Prior oncologic radiation to the sampled gluteal region.
- Declined consent for research use of surgical tissue.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Tissue Sampling During Clinically Indicated SurgerySamples 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. | Procedure or surgery | Prospective Histopathology Cohort |
| Blinded Histopathologic ScoringTwo 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. | Other | Prospective Histopathology Cohort |
Primary outcome
Composite Histopathologic Severity Score by Clinical-Radiologic Stage
Time frame: At the index operation and final blinded histopathology assessment of the surgical specimen. 3 months
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.
1 secondary outcome
Prevalence of Individual Histopathologic Features
Time frame: At final histopathology assessment of the index surgical specimen. 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 39410973Pachon Suarez JE, Tello VZR, Cifuentes RCR, Cuadros AMP, Salazar MC. Biopolymers: Histopathologic Case Series of Patients with Permanent Synthetic Fillers Presenting Chronic Granulomatous Reaction and Hypercalcemia. Plast Reconstr Surg Glob Open. 2024 Oct 15;12(10):e6159. doi: 10.1097/GOX.0000000000006159. eCollection 2024 Oct.
- Background: PubMed 35233337Pachon Suarez JE, Salazar MC, Rizo VZ. Classification for Staging and Managing Patients with Biopolymer-induced Human Adjuvant Disease. Plast Reconstr Surg Glob Open. 2022 Feb 24;10(2):e4137. doi: 10.1097/GOX.0000000000004137. eCollection 2022 Feb.
- Background: PubMed 29989569Xu T, Zhang J, Zhu Y, Zhao W, Pan C, Ma H, Zhang L. A poly(hydroxyethyl methacrylate)-Ag nanoparticle porous hydrogel for simultaneous in vivo prevention of the foreign-body reaction and bacterial infection. Nanotechnology. 2018 Sep 28;29(39):395101. doi: 10.1088/1361-6528/aad257. Epub 2018 Jul 10.
- Background: PubMed 42495057Osorio E, Ramirez B, Herrera O, Suarez C, Ciro C, Varela A. Three-flap Technique: Comprehensive Approach for Biopolymer Removal in the Gluteal and Lumbar Regions. Plast Reconstr Surg Glob Open. 2026 Jul 23;14(7):e7870. doi: 10.1097/GOX.0000000000007870. eCollection 2026 Jul.
- Individual participant dataSharing planned: No. not considered in the informed consent of the patients
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The GranStone Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edison Osorio, MD, plastic surgery principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foreign-Body Reaction and Granulomatous Disease, run by Research Inc at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edison Osorio, MD, Plastic surgeon (+573226140611, info@edisonosorio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Histopathologic Severity Score by Clinical-Radiologic Stage (time frame: At the index operation and final blinded histopathology assessment of the surgical specimen. 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07808970, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.