An observational study in Foreign-Body Reaction, Soft Tissue Filler Complication and Gluteal Permanent Synthetic Filler Disease, sponsored by Research Inc. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Research Inc · Observational
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
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.
Research Inc is the lead sponsor of 24 studies on the registry; 22 are open to participants now.
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Adults with prior gluteal injection of permanent synthetic fillers who undergo preoperative pelvic/gluteal MRI and are scheduled for surgical removal or exploration.
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.
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.
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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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each participant has the same MRI interpreted with the conventional qualitative format and with the structured anatomic classification before the index operation.
Diagnostic Test: Conventional Qualitative MRI Interpretation · Diagnostic Test: Structured Gluteal Filler MRI Classification · Procedure: Standardized Intraoperative Anatomic Mapping
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.
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.
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.
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.
Time frame: Preoperative MRI interpretation and the index surgical procedure performed within 90 days after MRI. 90 days
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.
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
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.
Time frame: 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.
Time frame: Immediately after review of each preoperative MRI report. 1 day
No study locations are listed for this record.
Plan to share: No — no, due the privacity and informed consents signed by the patients
Start is estimated for Oct 2026; primary completion for Dec 2026, 2 months later.
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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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Foreign-Body Reaction