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Prospective agreement study of magnetic resonance imaging measurements and intraoperative dimensions during gluteal permanent synthetic filler removal

NCT ID NCT07808996

NEW Sponsor: Research Inc Source: ClinicalTrials.gov ↗

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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.
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Paused for now. It may or may not start again.
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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 Results may not be published yet.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)

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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

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Status unknown
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First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

This prospective agreement study will compare preoperative MRI measurements with direct surgical measurements in adults undergoing removal of gluteal tissue affected by permanent synthetic fillers. MRI will estimate affected-tissue dimensions and residual skin-flap thickness at predefined landmarks. During surgery, the same flap landmarks and the fresh excised specimen will be measured. The primary outcome is agreement between MRI and intraoperative flap thickness; postoperative ischemia, wound dehiscence, and necrosis will be followed through 30 days.

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Study facts

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

Participants

About 220 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 2027

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 scheduled for surgical excision of gluteal tissue affected by permanent synthetic fillers after preoperative MRI.

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. * 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.

Foreign-Body Reaction

As listed by the trial registrant

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

Foreign-body reaction Gluteal tissue ischemia risk Soft tissue filler complication

How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. 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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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

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