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Clinical Trials/NCT06903208
NCT06903208
Recruiting
Not Applicable

Radiofrequency Ablation as a Scar-free, Non-operative Approach to Treatment of Superficial Lipomas

Columbia University1 site in 1 country10 target enrollmentStarted: April 2, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
10
Locations
1
Primary Endpoint
Patient Satisfaction

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Patient Satisfaction

Time Frame: 1 month, 6 months and 12 months post-procedure

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?"

Change in Lesion Volume

Time Frame: Baseline, 1 month, 6 months and 12 months post-procedure

Lesion volume change from baseline to 1 year.

Secondary Outcomes

  • Complication rate(1 month, 6 months and 12 months post-procedure)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Katherine Fischkoff

Associate Professor of Surgery in Anesthesiology

Columbia University

Study Sites (1)

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