An interventional study of STARMed VIVA Combo RF System in Lipoma, sponsored by Columbia University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Columbia University · Not applicable, Interventional, and Treatment
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.
22 studies on the registry are indexed under Lipoma; 6 are open to participants now.
This study's planned enrollment of 10 is below the median of 30 across 17 interventional studies indexed under Lipoma.
Browse Lipoma studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
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Exclusion Criteria:
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
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)
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?"
Time frame: 1 month, 6 months and 12 months post-procedure
Change in Lesion Volume
Lesion volume change from baseline to 1 year.
Time frame: Baseline, 1 month, 6 months and 12 months post-procedure
Complication rate
Number of any complications after treatment.
Time frame: 1 month, 6 months and 12 months post-procedure
Started Apr 2025 (actual). Primary completion is estimated for Jul 2027, 27 months after the start.
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