RFA for Superficial Lipomas

Not Applicable

Recruiting

• Conditions: Lipoma

• Registration Number: NCT06903208
• Lead Sponsor: Columbia University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Study Start: 2025-06
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction	1 month, 6 months and 12 months post-procedure	Patient satisfaction will be measured by self-reporting on a Likert scale asking whether they would recommend the procedure: "On a scale of 1 (would not recommend) to 5 (would highly recommend), how likely would you be to recommend RFA treatment of a lipoma to a friend?"
Change in Lesion Volume	Baseline, 1 month, 6 months and 12 months post-procedure	Lesion volume change from baseline to 1 year.

Secondary Outcome Measures

Name	Time	Method
Complication rate	1 month, 6 months and 12 months post-procedure	Number of any complications after treatment.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States