Can a structured MRI reading map filler complications better?

NCT ID NCT07808463

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Foreign-Body Reaction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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Contacts and locations

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