Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Inside the tissue: how permanent butt fillers scar and destroy

NCT ID NCT07808970

Knowledge-focused Sponsor: Research Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are studying tissue removed during surgery from adults who developed complications after permanent gluteal filler injections. Two pathologists, working without knowing the clinical details, grade eight features including filler burden, inflammation, fibrosis, fat death, and injury to blood vessels, lymphatics, muscle, and skin. The team compares these scores across clinical stages and time since injection to propose a model of how the condition evolves and to test whether the scoring system gives consistent results.

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 the scoring system holds up, doctors could gain a shared language for staging gluteal filler complications and matching treatment to severity.
What could go wrong
The study only samples tissue from people who already need surgery, so it may miss milder cases and cannot prove what causes the damage. Two pathologists reading slides can still disagree.

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 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 undergoing biopsy or surgical removal of gluteal tissue affected by permanent synthetic filler, spanning early exposure through advanced disease with ulceration or necrosis.

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. * Prior gluteal injection of a permanent or unknown nonresorbable filler. * Clinically indicated biopsy or surgical excision yielding tissue suitable for histopathologic evaluation. * Available history of approximate injection date and standardized preoperative clinical staging. * Written consent for tissue analysis and optional future use of deidentified specimens. Exclusion Criteria: * Specimen composed only of scar or skin without tissue from the filler-affected region. * Insufficient tissue quality for routine histology. * Acute bacterial infection that precludes distinction of the underlying chronic tissue response unless infection is itself a prespecified advanced-stage feature. * Prior oncologic radiation to the sampled gluteal region. * Declined consent for research use of surgical tissue.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Foreign-body reaction are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Fat Necrosis Fibrosis Foreign-Body Reaction Granuloma, Foreign-Body

As listed by the trial registrant

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

Foreign-body reaction Gluteal permanent synthetic filler disease Granulomatous disease Soft tissue necrosis lower limb

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

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

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Clinica Bioforma

    Medellín, Antioquia, Colombia

    Contact Email: •••••@•••••

More trials for these conditions

Other studies related to the condition(s) this trial covers.