RFA for Superficial Lipomas
ConditionLipoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients >18 years old
Patients with a lipoma <5 cm, above the fascia on the trunk, abdomen or extremities
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
STARMed VIVA Combo RF System
DeviceRFA 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Radiofrequency ablation (RFA)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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-procedure2
Change in Lesion Volume
Lesion volume change from baseline to 1 year.
Time frame
Baseline, 1 month, 6 months and 12 months post-procedureSecondary outcomes
1
Complication rate
Number of any complications after treatment.
Time frame
1 month, 6 months and 12 months post-procedureSponsors and contacts
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Source ClinicalTrials.gov