RFA for Superficial Lipomas

NCT06903208 | Recruiting FDA Device

• 1 other identifier: AAAV2254
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipoma

Keywords

lipoma; ablation; fatty tissue; fatty tumor; scarring; minimally invasive

Outcome Measures

Primary Outcomes (2)

• Patient Satisfaction

  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?"

  1 month, 6 months and 12 months post-procedure

• Change in Lesion Volume

  Lesion volume change from baseline to 1 year.

  Baseline, 1 month, 6 months and 12 months post-procedure

Secondary Outcomes (1)

• Complication rate

  1 month, 6 months and 12 months post-procedure

Study Arms (1)

Radiofrequency ablation (RFA)

EXPERIMENTAL

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

Device: STARMed VIVA Combo RF System

Interventions

STARMed VIVA Combo RF System DEVICE

RFA is a kind of treatment that uses a long thin needle, called a probe, to melt the lipoma. After numbing the skin with a local anesthetic, using an ultrasound machine as a guide, the study surgeon will insert the probe into the center of the lipoma. The probe will then deliver heat to the lipoma, melting it. The ultrasound is a machine which bounces sound waves to create an image that the study doctor sees on a screen. These ultrasound images will help the study surgeon to accurately guide the probe to the correct location of the lipoma. Once the lipoma is melted, the study surgeon will aspirate any residual liquid out.

Also known as: Radiofrequency Ablation (RFA)

Radiofrequency ablation (RFA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>18 years old
• Patients with a lipoma \<5 cm, above the fascia on the trunk, abdomen or extremities

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Lipoma; Cicatrix

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Katherine Fischkoff, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery in Anesthesiology

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: April 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

US (1)