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Can a glowing dye save tissue during buttock filler removal?

NCT ID NCT07808957

Prevention 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 testing whether a fluorescent dye called indocyanine green helps surgeons judge blood flow in buttock tissue during removal of permanent synthetic fillers. Participants scheduled for this operation are assigned at random to either dye-guided imaging or standard clinical assessment. The trial tracks wound complications such as poor blood flow, wound reopening, and tissue death for 30 days after surgery, along with dye reactions, infections, and repeat operations.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
indocyanine green, a fluorescent dye given intravenously
What this could lead to
If it works, surgeons could use a dye and special camera to see which tissue has healthy blood flow during filler removal, possibly lowering the risk of wound breakdown and tissue death.
What could go wrong
The dye may not change outcomes compared with a surgeon's own judgment, and it can cause allergic reactions. The trial is randomized but the approach is not yet proven.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 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

Oct 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.

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 to 65 years. * Scheduled for elective gluteal permanent synthetic filler removal with flap elevation and primary closure. * Expected availability of the study fluorescence imaging system. * Ability to provide written informed consent and complete 90-day wound follow-up. Exclusion Criteria: * Known hypersensitivity to indocyanine green. * Pregnancy or breastfeeding. * Emergency surgery, uncontrolled sepsis, or hemodynamic instability at the time of randomization. * Severe hepatic dysfunction or another condition judged by anesthesia to make indocyanine green inappropriate. * Prior enrollment in this trial for a contralateral or repeat operation. * Inability to undergo standardized postoperative wound assessment.

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As listed by the trial registrant

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

Soft tissue filler complication Surgical flap ischemia Tissue necrosis

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

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  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Clinica Bioforma

    Medellín, Colombia

    Contact Email: •••••@•••••

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