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?

Lipomas are non-cancerous growths of fatty tissue that develop under the skin in approximately 1 in 1000 people, though this number may be higher. While rarely symptomatic, they often cause emotional distress due to the unappealing appearance of the mass. Treatment of unsightly lipomas is excision with local anesthetic in the office or with sedation in the operating room. 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 defer surgical excision because excision of a lipoma is a cosmetic procedure, but the aesthetic outcome is undesirable. Radiofrequency ablation (RFA) is a technique that applies heat generated by a high frequency, alternating current to soft tissue. The hyperthermia produced by the current causes tissue necrosis that ablates the tissue into which the energy is directed. RFA has been successfully applied to thyroid nodules, pancreatic lesions, esophageal dysplasia and liver tumors. However, the manufacturers of the RFA technology have been focused on its application in pre-malignant and malignant lesions and have not yet considered its application to benign tumors. This study will test the success of RFA for superficial lipomas as a non-surgical option for treatment.

Will I have to stop taking my current medications?

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

Is radiofrequency ablation generally safe for humans?

Radiofrequency ablation (RFA) is generally considered a very safe procedure with rare severe complications, as shown in studies involving its use for varicose veins and liver cancer. ^{1 2 3 4 5}

How is the treatment Radiofrequency Ablation (RFA) for lipomas different from other treatments?

Radiofrequency Ablation (RFA) is unique because it uses heat generated by radio waves to destroy tissue, offering a minimally invasive option compared to surgical removal. This method is typically used for small tumors and is known for its precision and reduced recovery time. ^{6 7 8 9 10}

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. United States pubmed.ncbi.nlm.nih.gov

Liposuction of lipomas. [2005]

2. England pubmed.ncbi.nlm.nih.gov

Complications of radiofrequency ablation of varicose veins. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Pitfalls in the radiological and pathological correlation of tumour response rates of hepatocellular carcinoma following radiofrequency ablation. [2009]

4. Malaysia pubmed.ncbi.nlm.nih.gov

Comparison of Non-Operative Mesotherapy and Surgery in the Management of Superficial Lipomas. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The benefits of powered liposuction versus traditional liposuction: a paired comparison analysis. [2019]

6. Greece pubmed.ncbi.nlm.nih.gov

Laparoscopic radiofrequency ablation of unresectable hepatic malignancies: indication, limitation and results. [2008]

7. England pubmed.ncbi.nlm.nih.gov

Numerical analysis of the relationship between the area of target tissue necrosis and the size of target tissue in liver tumours with pulsed radiofrequency ablation. [2019]

8. Italy pubmed.ncbi.nlm.nih.gov

A review of radiofrequency ablation: Large target tissue necrosis and mathematical modelling. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided radiofrequency ablation in gastroenterology: New horizons in search. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Complications of radiofrequency ablation of neoplasms. [2021]