RFA for Superficial Lipomas

NCT ID: NCT06903208

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-02
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiofrequency ablation (RFA)

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

Group Type: EXPERIMENTAL

STARMed VIVA Combo RF System

Intervention Type: 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.

Interventions

STARMed VIVA Combo RF System

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.

Intervention Type: DEVICE

Other Intervention Names

Radiofrequency Ablation (RFA)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Katherine Fischkoff

Associate Professor of Surgery in Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine Fischkoff, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Katherine Fischkoff, MD

Role: primary

kf2403@cumc.columbia.edu

212-342-1734

Other Identifiers

AAAV2254

Identifier Type: -

Identifier Source: org_study_id