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Can heat melt away lipomas without a scalpel?

NCT ID NCT06903208

Symptom relief Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial tests whether radiofrequency ablation (RFA) can safely and effectively treat superficial lipomas—benign fatty lumps under the skin—without leaving a scar. Instead of cutting out the lipoma, a thin needle delivers heat to melt it, guided by ultrasound. The study will measure patient satisfaction, changes in lesion size, and complication rates in adults with small lipomas on the trunk, abdomen, or extremities.

What this could mean

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

Active substance
Radiofrequency ablation using the STARMed VIVA Combo RF System, a device that delivers heat through a needle to melt the lipoma.
What this could lead to
If successful, this could offer a scar-free alternative to surgical removal of lipomas, improving cosmetic outcomes and patient satisfaction.
What could go wrong
This is a very small early trial (10 people), so results may not apply broadly. Risks include incomplete ablation, recurrence, or complications like infection or skin burns.

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 10 people

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

Started

Apr 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Patients \>18 years old * Patients with a lipoma \<5 cm, above the fascia on the trunk, abdomen or extremities Exclusion Criteria: * Lipomas of the face or neck * Angiolipomas (identified on exam as a firm, mobile, occasionally discolored mass) * Patients with history of hereditary retinoblastoma, Li-Fraumeni syndrome, familial adenomatous polyposis, neurofibromatosis, tuberous sclerosis and Werner syndrome * A history of exposure to herbicides, arsenic and dioxin * A history of radiation treatment for other cancers

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Conditions

The condition(s) this trial relates to.

lipoma severe cutaneous adverse reaction

As listed by the trial registrant

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

Lipoma

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

Locations

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

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