Clinical trial · Interventional
RFA for Superficial Lipomas
Radiofrequency Ablation as a Scar-free, Non-operative Approach to Treatment of Superficial Lipomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lipoma | Lipoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| STARMed VIVA Combo RF System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiofrequency ablation (RFA)
- description
- As this is a single-arm study, all patients enrolled will get the study procedure/treatment of radiofrequency ablation (RFA).
- interventionNames
- Device: STARMed VIVA Combo RF System
Primary outcomes (2)
- measure
- Patient Satisfaction
- timeFrame
- 1 month, 6 months and 12 months post-procedure
- description
- 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?"
- measure
- Change in Lesion Volume
- timeFrame
- Baseline, 1 month, 6 months and 12 months post-procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available