Foreign-Body ReactionNCT07808463
Prospective Paired Evaluation of Conventional Versus Structured Magnetic Resonance Imaging Interpretation for Preoperative Assessment of Gluteal Permanent Synthetic Filler Disease
An observational study of Foreign-Body Reaction and Soft Tissue Filler Complication, run by Research Inc.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foreign-Body Reaction, Soft Tissue Filler Complication, Gluteal Permanent Synthetic Filler Disease
- What is being tested?
- Conventional Qualitative MRI Interpretation, Structured Gluteal Filler MRI Classification and Standardized Intraoperative Anatomic Mapping
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Dec 2026
- How long will I take part?
- 1 Day
- 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 with prior gluteal injection of permanent synthetic fillers who undergo preoperative pelvic/gluteal MRI and are scheduled for surgical removal or exploration.
Who may be able to join
- Age 18 years or older.
- History of gluteal injection with a permanent or unknown nonresorbable filler.
- Preoperative pelvic/gluteal MRI performed using the study acquisition protocol.
- Planned surgical removal, biopsy, or operative exploration within 90 days after MRI.
- Written informed consent for paired image interpretation and use of operative findings.
Who cannot join
- MRI contraindication or nondiagnostic imaging caused by motion or incomplete anatomic coverage.
- Prior extensive gluteal filler removal that prevents mapping of the predefined compartments.
- No operative procedure within 90 days after MRI and therefore no reference-standard assessment.
- Acute life-threatening infection or emergency surgery that prevents completion of the preoperative reporting sequence.
- Inability to provide consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
Read the detailed description
Eligible participants will undergo a standardized pelvic and gluteal MRI before planned filler-removal surgery. The same examination will be interpreted using two prespecified formats: a conventional qualitative report and a structured report that grades involvement of the fat-fascia interface, subcutaneous fat, deep fascia, gluteal muscles, subcrestal, ischial, trochanteric, and pelvic-ring regions, as well as lymphatic and interstitial pathways. The operating surgeon will record a preliminary plan and utility rating after each report. During surgery, actual compartment involvement will be documented using a standardized map and, when available, specimen and histopathologic findings. Paired diagnostic performance, inter-reader agreement, change in surgical planning, and associations with operative complexity will be analyzed.
- Conditions
- Foreign-Body Reaction, Soft Tissue Filler Complication, Gluteal Permanent Synthetic Filler Disease
- Being tested
- Conventional Qualitative MRI Interpretation, Structured Gluteal Filler MRI Classification, Standardized Intraoperative Anatomic Mapping
- Keywords
- Biopolymers, Permanent Synthetic Fillers, Magnetic Resonance Imaging, Structured Reporting, Preoperative Planning, Gluteal Region
- Medical subject headings
- Foreign-Body Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Qualitative MRI InterpretationDiagnostic test
The report records the presence or absence of injected foreign material in the gluteal region and any routinely reported findings. A preliminary surgical plan is recorded after review of this report. Linked arm/group(s): Paired MRI Interpretation Cohort.
Structured Gluteal Filler MRI ClassificationDiagnostic test
The report records material distribution and severity in predefined compartments: fat-fascia interface, subcutaneous fat, deep fascia, gluteal muscles, subcrestal region, ischial region, trochanteric region, pelvic ring, lymphatic pathways, and interstitial involvement. The final classification manual and grade definitions will be locked before enrollment. Linked arm/group(s): Paired MRI Interpretation Cohort.
Standardized Intraoperative Anatomic MappingProcedure or surgery
During the index operation, the surgeon documents actual involvement of each predefined compartment before reviewing the imaging accuracy analysis. Operative photographs, specimen mapping, and histopathology may support the reference standard. Linked arm/group(s): Paired MRI Interpretation Cohort.
| Study group | Role | What they receive |
|---|---|---|
| Paired MRI Interpretation Cohort | Each participant has the same MRI interpreted with the conventional qualitative format and with the structured anatomic classification before the index operation. Receives: Diagnostic Test: Conventional Qualitative MRI Interpretation; Diagnostic Test: Structured Gluteal Filler MRI Classification; Procedure: Standardized Intraoperative Anatomic Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for Surgically Confirmed Anatomic Compartment Involvement
For each reporting method, sensitivity is the number of predefined compartments identified as involved on MRI divided by the number confirmed as involved during standardized intraoperative mapping. The structured and conventional results will be compared within the same participant.
Measured: Preoperative MRI interpretation and the index surgical procedure performed within 90 days after MRI. 90 days
Secondary outcomes (3)
Specificity for Surgically Uninvolved Anatomic Compartments
For each method, specificity is the number of compartments correctly identified as uninvolved on MRI divided by the number documented as uninvolved at surgery.
Measured: Preoperative MRI interpretation and the index surgical procedure performed within 90 days after MRI. 90 dys
Change in Preoperative Surgical Plan After Structured MRI Review
Proportion of participants for whom the recorded operative plan changes after the structured report, including planned incision, extent of excision, anticipated deep-plane dissection, lymphatic evaluation, or reconstruction strategy.
Measured: Immediately after the conventional report and immediately after the structured report, both before surgery. 1 day
Surgeon-Rated MRI Report Utility
The operating surgeon rates completeness, anatomic clarity, confidence, and usefulness for planning on prespecified 0-to-10 scales after each report. Higher scores indicate greater perceived utility.
Measured: Immediately after review of each preoperative MRI report. 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Foreign-Body ReactionStudies of the same condition, open and under way.
- More trials run by Research IncThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Day
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
- NCT07808463
- Sponsor's protocol ID
- 007
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no, due the privacity and informed consents signed by the patients
Publications
Osorio 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 42495057Yahyavi-Firouz-Abadi N, Menias CO, Bhalla S, Siegel C, Gayer G, Katz DS. Imaging of cosmetic plastic procedures and implants in the body and their potential complications. AJR Am J Roentgenol. 2015 Apr;204(4):707-15. doi: 10.2214/AJR.14.13516.
PubMed 25794060Niasme E, Delattre BMA, Lenoir V, Modarressi A, Poletti PA, Becker M, Boudabbous S. Quantitative magnetic resonance imaging: differentiating soft tissue implants and fillers used in cosmetic and reconstructive surgery. Skeletal Radiol. 2021 Jan;50(1):231-237. doi: 10.1007/s00256-020-03564-z. Epub 2020 Aug 5.
PubMed 32761256Soliman SB. Liquid silicone filler migration following illicit gluteal augmentation. Radiol Case Rep. 2023 Jan 5;18(3):984-990. doi: 10.1016/j.radcr.2022.12.049. eCollection 2023 Mar.
PubMed 36636483Leyva A, Tran T, Cibulas AT, Warden D, Danger FJ, Scherer K, Wasyliw C. Filler Migration and Granuloma Formation After Gluteal Augmentation with Free-silicone Injections. Cureus. 2018 Sep 13;10(9):e3294. doi: 10.7759/cureus.3294.
PubMed 30443464
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Paired Evaluation of Conventional Versus Structured Magnetic Resonance Imaging Interpretation for Preoperative Assessment of Gluteal Permanent Synthetic Filler Disease
- ClinicalTrials.gov ID
- NCT07808463
- Acronym / sponsor ID
- 007
- Conditions
- Foreign-Body Reaction, Soft Tissue Filler Complication, Gluteal Permanent Synthetic Filler Disease
- Keywords
- Biopolymers, Permanent Synthetic Fillers, Magnetic Resonance Imaging, Structured Reporting, Preoperative Planning, Gluteal Region
- 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 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 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 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
Detailed description
Eligible participants will undergo a standardized pelvic and gluteal MRI before planned filler-removal surgery. The same examination will be interpreted using two prespecified formats: a conventional qualitative report and a structured report that grades involvement of the fat-fascia interface, subcutaneous fat, deep fascia, gluteal muscles, subcrestal, ischial, trochanteric, and pelvic-ring regions, as well as lymphatic and interstitial pathways. The operating surgeon will record a preliminary plan and utility rating after each report. During surgery, actual compartment involvement will be documented using a standardized map and, when available, specimen and histopathologic findings. Paired diagnostic performance, inter-reader agreement, change in surgical planning, and associations with operative complexity will be analyzed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paired MRI Interpretation Cohort | – | Diagnostic Test: Conventional Qualitative MRI Interpretation, Diagnostic Test: Structured Gluteal Filler MRI Classification, Procedure: Standardized Intraoperative Anatomic MappingEach participant has the same MRI interpreted with the conventional qualitative format and with the structured anatomic classification before the index operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with prior gluteal injection of permanent synthetic fillers who undergo preoperative pelvic/gluteal MRI and are scheduled for surgical removal or exploration.
Key inclusion criteria (5 listed)
- Age 18 years or older.
- History of gluteal injection with a permanent or unknown nonresorbable filler.
- Preoperative pelvic/gluteal MRI performed using the study acquisition protocol.
- Planned surgical removal, biopsy, or operative exploration within 90 days after MRI.
- Written informed consent for paired image interpretation and use of operative findings.
Key exclusion criteria (5 listed)
- MRI contraindication or nondiagnostic imaging caused by motion or incomplete anatomic coverage.
- Prior extensive gluteal filler removal that prevents mapping of the predefined compartments.
- No operative procedure within 90 days after MRI and therefore no reference-standard assessment.
- Acute life-threatening infection or emergency surgery that prevents completion of the preoperative reporting sequence.
- Inability to provide consent.
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 |
|---|---|---|
| Conventional Qualitative MRI InterpretationThe report records the presence or absence of injected foreign material in the gluteal region and any routinely reported findings. A preliminary surgical plan is recorded after review of this report. Linked arm/group(s): Paired MRI Interpretation Cohort. | Diagnostic test | Paired MRI Interpretation Cohort |
| Structured Gluteal Filler MRI ClassificationThe report records material distribution and severity in predefined compartments: fat-fascia interface, subcutaneous fat, deep fascia, gluteal muscles, subcrestal region, ischial region, trochanteric region, pelvic ring, lymphatic pathways, and interstitial involvement. The final classification manual and grade definitions will be locked before enrollment. Linked arm/group(s): Paired MRI Interpretation Cohort. | Diagnostic test | Paired MRI Interpretation Cohort |
| Standardized Intraoperative Anatomic MappingDuring the index operation, the surgeon documents actual involvement of each predefined compartment before reviewing the imaging accuracy analysis. Operative photographs, specimen mapping, and histopathology may support the reference standard. Linked arm/group(s): Paired MRI Interpretation Cohort. | Procedure or surgery | Paired MRI Interpretation Cohort |
Primary outcome
Sensitivity for Surgically Confirmed Anatomic Compartment Involvement
Time frame: Preoperative MRI interpretation and the index surgical procedure performed within 90 days after MRI. 90 days
For each reporting method, sensitivity is the number of predefined compartments identified as involved on MRI divided by the number confirmed as involved during standardized intraoperative mapping. The structured and conventional results will be compared within the same participant.
3 secondary outcomes
Specificity for Surgically Uninvolved Anatomic Compartments
Time frame: Preoperative MRI interpretation and the index surgical procedure performed within 90 days after MRI. 90 dys
Change in Preoperative Surgical Plan After Structured MRI Review
Time frame: Immediately after the conventional report and immediately after the structured report, both before surgery. 1 day
Surgeon-Rated MRI Report Utility
Time frame: Immediately after review of each preoperative MRI report. 1 day
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 8 Sep 2026.
- 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.
- Background: PubMed 25794060Yahyavi-Firouz-Abadi N, Menias CO, Bhalla S, Siegel C, Gayer G, Katz DS. Imaging of cosmetic plastic procedures and implants in the body and their potential complications. AJR Am J Roentgenol. 2015 Apr;204(4):707-15. doi: 10.2214/AJR.14.13516.
- Background: PubMed 32761256Niasme E, Delattre BMA, Lenoir V, Modarressi A, Poletti PA, Becker M, Boudabbous S. Quantitative magnetic resonance imaging: differentiating soft tissue implants and fillers used in cosmetic and reconstructive surgery. Skeletal Radiol. 2021 Jan;50(1):231-237. doi: 10.1007/s00256-020-03564-z. Epub 2020 Aug 5.
- Background: PubMed 36636483Soliman SB. Liquid silicone filler migration following illicit gluteal augmentation. Radiol Case Rep. 2023 Jan 5;18(3):984-990. doi: 10.1016/j.radcr.2022.12.049. eCollection 2023 Mar.
- Background: PubMed 30443464Leyva A, Tran T, Cibulas AT, Warden D, Danger FJ, Scherer K, Wasyliw C. Filler Migration and Granuloma Formation After Gluteal Augmentation with Free-silicone Injections. Cureus. 2018 Sep 13;10(9):e3294. doi: 10.7759/cureus.3294.
- Individual participant dataSharing planned: No. no, due the privacity and informed consents signed by the patients
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Foreign-Body Reaction and Soft Tissue Filler Complication, run by Research Inc.
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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Sensitivity for Surgically Confirmed Anatomic Compartment Involvement (time frame: Preoperative MRI interpretation and the index surgical procedure performed within 90 days after MRI. 90 days). 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 NCT07808463, which also lists 5 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 8 Sep 2026.