Can a structured MRI reading map filler complications better?
NCT ID NCT07808463
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This trial tests whether a structured MRI reading method helps surgeons see the full extent of permanent filler complications in the buttocks better than the standard approach. Adults who had gluteal filler injections and are scheduled for surgery will get both types of MRI reports. The researchers compare each report against what surgeons actually find during the operation to see which method is more accurate.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Structured MRI interpretation method
- What this could lead to
- If the structured method proves more accurate, it could help surgeons plan operations for gluteal filler complications, potentially reducing incomplete removals or repeat surgeries.
- What could go wrong
- The trial is a diagnostic study, not a treatment test. The structured method may not improve accuracy enough to change surgical plans, and results depend on the skill of radiologists and the quality of MRI scans.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adults with prior gluteal injection of permanent synthetic fillers who undergo preoperative pelvic/gluteal MRI and are scheduled for surgical removal or exploration.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Randomized evaluation of indocyanine green fluorescence Angiography-Guided versus standard clinical perfusion assessment during gluteal permanent synthetic filler removal
- Prospective Stage-Stratified histopathologic study and proposed Disease-Evolution model of gluteal permanent synthetic filler complications
- Prospective agreement study of magnetic resonance imaging measurements and intraoperative dimensions during gluteal permanent synthetic filler removal
- Which surgical tool causes less tissue damage? a Head-to-Head test