Columbia University Irving Medical Center
New York, 10032, United States
Location status: Recruiting
NCT Number: NCT06903208
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New York, 10032, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Radiofrequency Ablation (RFA)
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?"
Time frame: Baseline, 1 month, 6 months and 12 months post-procedure
Lesion volume change from baseline to 1 year.
Time frame: 1 month, 6 months and 12 months post-procedure
Number of any complications after treatment.
Columbia University
Other
Radiofrequency Ablation as a Scar-free, Non-operative Approach to Treatment of Superficial Lipomas
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07441538
Cicatrix, Cyst
Wuhan, Hubei, China
View Trial DetailsNCT07384299
Cicatrix, Cyst
Wuhan, Hubei, China
View Trial DetailsNCT07237425
Lipoma, Neoplasms
Taipei, Da'an District, Taiwan
View Trial DetailsNCT06820164
Lipoma, Neoplasms
Morgantown, West Virginia, United States
View Trial Details