Radiofrequency Ablation as a Scar-free, Non-operative Approach to Treatment of Superficial Lipomas

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients \>18 years old

• Patients with a lipoma \<5 cm, above the fascia on the trunk, abdomen or extremities

Locations
United States
New York
Columbia University Irving Medical Center
RECRUITING
New York
Time Frame
Start Date: 2025-04-02
Estimated Completion Date: 2026-12
Participants
Target number of participants: 10
Treatments
Experimental: Radiofrequency ablation (RFA)
As this is a single-arm study, all patients enrolled will get the study procedure/treatment of radiofrequency ablation (RFA).
Related Therapeutic Areas
Sponsors
Leads: Columbia University

This content was sourced from clinicaltrials.gov