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Which surgical tool causes less tissue damage? a Head-to-Head test

NCT ID NCT07765576

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This study compares two electrocautery tips—blunt and Utah—to see which causes less thermal damage to fat, fibrotic, and muscle tissue. Tissue samples are taken from patients undergoing surgical removal of gluteal biopolymers (injected fillers). The tissue is cut in the lab using different tips, power settings, and modes, and the depth of damage is measured under a microscope. The goal is to identify which tool and settings minimize tissue injury, potentially improving surgical outcomes.

What this could mean

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

Active substance
Blunt electrocautery tip versus Utah electrocautery tip
What this could lead to
If one tip causes less tissue damage, it could guide surgeons to choose tools that reduce post-surgical scarring and improve recovery.
What could go wrong
This is a small lab-based study on tissue samples, not a patient treatment trial. Results may not translate to real-world surgical outcomes.

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 50 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 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

The study population will be drawn from patients treated at Clínica Bioderma in Medellín, Colombia, who are scheduled to undergo clinically indicated surgical removal of gluteal tissue affected by prior biopolymer injection. Participants will represent the clinical population managed by the principal investigator for surgical treatment of gluteal biopolymer infiltration. The ex vivo thermal and histopathological assessments will be performed only on tissue already removed during the planned surgical procedure.

Ages

18 to 55 years

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: * Patients with clinical and/or imaging diagnosis of gluteal soft tissue infiltration by biopolymers or alloplastic filler material. * Patients scheduled for clinically indicated surgical removal of gluteal biopolymer-infiltrated tissue. * Ability to understand the study and provide written informed consent. * Availability of explanted tissue suitable for ex vivo thermal and histopathological assessment. Exclusion Criteria: * Refusal or inability to provide informed consent. * Intraoperative finding that explanted tissue is insufficient for ex vivo thermal assessment. * Active severe infection requiring urgent deviation from the planned surgical protocol. * Extensive tissue necrosis or contamination preventing standardized ex vivo thermal assessment. * Specimens that cannot be processed within the predefined time window after explantation. * Any situation in which the surgeon determines that research handling of the specimen could interfere with clinical care, pathology required for patient management, or institutional tissue handling policies. * Lack of adequate thermographic recording due to technical failure.

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Conditions

The condition(s) this trial relates to.

Foreign Bodies Foreign-Body Reaction Granuloma, Foreign-Body

As listed by the trial registrant

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

Foreign bodies Foreign-body reaction Granuloma, foreign-body Soft tissue disease Thermal injury response

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 Bioderma

    Medellín, Antioquia, 050022, Colombia

    Contact Email: •••••@•••••

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