Recruiting

RFA

Sponsor:

Columbia University

Code:

NCT06903208

Conditions

Lipoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STARMed VIVA Combo RF System

Study Details

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 ID

NCT06903208

Start date

Apr 2, 2025

Status verified date

Aug, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Radiofrequency ablation (RFA)

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

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.

Primary outcome measure

  • Patient Satisfaction [ Time Frame: 1 month, 6 months and 12 months post-procedure ]
  • Change in Lesion Volume [ Time Frame: Baseline, 1 month, 6 months and 12 months post-procedure ]

Central Contacts and Locations

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Katherine Fischkoff, MD

212-342-1734kf2403@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-08-14.