Radiofrequency Ablation for Lipomas

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Angiolipomas, Hereditary retinoblastoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called radiofrequency ablation (RFA) for lipomas, which are non-cancerous lumps of fatty tissue under the skin. RFA uses heat to shrink or destroy tissue and might provide a scar-free alternative to surgery for those concerned about the appearance of lipomas. The trial includes individuals with a lipoma smaller than 5 cm on their trunk, abdomen, or limbs. Participants cannot have certain genetic conditions or lipomas on their face or neck. The study aims to determine if RFA can serve as a better cosmetic option for removing lipomas. As an unphased trial, it offers participants the opportunity to explore a potentially scar-free treatment for lipomas.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that radiofrequency ablation is safe for treating lipomas?

A previous study showed that radiofrequency ablation (RFA) reduced the size of neck lipomas by 53% with partial treatment. This indicates that RFA can effectively shrink these fatty lumps under the skin. The procedure is generally easy to manage and considered low risk, though it may leave a visible scar at the treatment site.

RFA has been safely used for other conditions, such as thyroid nodules and liver tumors, which supports its safety profile. Recovery from the procedure is typically quick, making it an appealing non-surgical option. While considering possible side effects is important, existing research suggests that RFA is a safe choice for treating lipomas. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Radiofrequency Ablation (RFA) is unique because it offers a minimally invasive way to treat lipomas by using heat to destroy the fatty tissue. Unlike traditional surgical removal, which can involve longer recovery times and potential scarring, RFA is typically quicker and less invasive. Researchers are excited about RFA because it might provide a more efficient treatment with fewer side effects, making it a promising alternative to surgery for those with lipomas.

What evidence suggests that radiofrequency ablation is effective for treating lipomas?

Research has shown that radiofrequency ablation (RFA) might effectively treat lipomas, which are fatty lumps under the skin. In one study, RFA was used to shrink facial lipomas, yielding promising results. Another study found that RFA reduced the size of lipomas by 53% when only part of the lump was treated. RFA uses heat to destroy fatty tissue and has already succeeded in treating other growths like thyroid nodules and liver tumors. RFA is considered safe, with serious complications being rare, making it a possible non-surgical option for those wishing to avoid scars from traditional surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Katherine Fischkoff, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for individuals with non-cancerous fatty growths called lipomas, which are typically harmless but can cause emotional distress due to their appearance. Candidates should be seeking a cosmetic solution without the scarring that comes from surgical removal.

Inclusion Criteria

I have a small, soft lump above the muscle layer on my trunk, belly, or limbs.

I am over 18 years old.

Exclusion Criteria

I have been exposed to herbicides, arsenic, or dioxin.

I have had radiation treatment for another cancer.

I have a lipoma on my face or neck.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radiofrequency ablation (RFA) for superficial lipomas

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and patient satisfaction after treatment

12 months

3 visits (in-person) at 1 month, 6 months, and 12 months post-procedure

What Are the Treatments Tested in This Trial?

Interventions

• Radiofrequency Ablation (RFA)

Trial Overview The study is testing the STARMed VIVA Combo RF System's effectiveness in treating superficial lipomas using Radiofrequency Ablation (RFA), a technique that uses heat to destroy tissue, as a non-surgical alternative.

How Is the Trial Designed?

Group I: Radiofrequency ablation (RFA) Experimental Treatment 1 Intervention

As this is a single-arm study, all patients enrolled will get the study procedure/treatment of radiofrequency ablation (RFA).

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06903208

Study Details | NCT06903208 | RFA for Superficial Lipomas The recovery period is short and the procedure is low risk; however, the result of the operation is a visible scar over the site of the lipoma. Many patients ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40307610/

Minimally invasive thermal ablation techniques for neck ... RFA achieved 53% volume reduction with partial ablation, while MWA resulted in remarkable reductions (81%, 86%, and 90% at 1, 3, and 6 months). Thermal ablation ...

3. link.springer.com link.springer.com/article/10.1007/s00266-024-04091-1

A Novel Approach for Treating Lipomas: Percutaneous ... In 2018, Ji Yeon Hong successfully demonstrated the reduction of facial lipomas using radiofrequency ablation [21].

4. withpower.com withpower.com/trial/phase-lipoma-5-2025-3b433

Radiofrequency Ablation for Lipomas Radiofrequency ablation (RFA) is generally considered a very safe procedure with rare severe complications, as shown in studies involving its use for varicose ...

5. nature.com nature.com/articles/s41598-021-03802-x

Microwave versus radiofrequency ablation for the treatment ... This randomized phase 2 clinical trial compares the effectiveness of MWA and RFA as well as morphology of corresponding ablation zones.

6. researchgate.net researchgate.net/publication/391327994_Minimally_invasive_thermal_ablation_techniques_for_neck_lipomas_RFA_vs_MWA

Minimally invasive thermal ablation techniques for neck ... Two cases of RFA and MWA for neck lipomas were evaluated over 6 months. RFA achieved 53% volume reduction with partial ablation, while MWA ...