Can MRI predict what surgeons find when removing gluteal fillers?
NCT ID NCT07808996
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers are studying whether MRI scans accurately measure gluteal tissue and skin-flap thickness before surgery to remove permanent synthetic fillers. Adults scheduled for elective excision of gluteal filler complications receive preoperative MRI, then surgeons measure the same landmarks directly during the operation. The study compares the two sets of measurements and tracks wound healing for 30 days after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If MRI proves reliable, surgeons could plan gluteal filler removal more precisely and reduce complications like wound breakdown and tissue death.
- What could go wrong
- This is an observational agreement study, not a treatment trial, so it cannot prove MRI improves outcomes. MRI may not match surgical measurements well enough to be useful, and the study does not test whether better planning actually prevents complications.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 220 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 2027
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 scheduled for surgical excision of gluteal tissue affected by permanent synthetic fillers after preoperative MRI.
- 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. * Gluteal permanent synthetic filler disease scheduled for elective surgical excision. * Preoperative MRI performed within 90 days before surgery using the study measurement protocol. * Planned skin/subcutaneous flap elevation that permits direct thickness measurement at predefined landmarks. * Written informed consent. Exclusion Criteria: * Emergency surgery or active uncontrolled infection that prevents standardized preoperative imaging or measurement. * Prior surgery causing loss of the predefined landmarks or making paired measurement impossible. * Nondiagnostic MRI or incomplete coverage of the planned operative field. * Specimen fragmentation that prevents standardized fresh-specimen dimension measurement for the secondary endpoint. * Inability to complete 30-day wound follow-up.
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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
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The official record
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Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
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