RFA for Superficial Lipomas

Columbia University

Status: Enrolling

Conditions: Lipoma

Treatments: Device: STARMed VIVA Combo RF System

Study type: Interventional

Funder types: Other

Identifiers

NCT06903208

AAAV2254

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Radiofrequency ablation (RFA)

Experimental group

Description:

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

Treatment:

Device: STARMed VIVA Combo RF System