RFA for Superficial Lipomas

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Patient Satisfaction [Срок оценки: 1 month, 6 months and 12 months post-procedure]
• Change in Lesion Volume [Срок оценки: Baseline, 1 month, 6 months and 12 months post-procedure]

Вторичные конечные точки (1)

• Complication rate [Срок оценки: 1 month, 6 months and 12 months post-procedure]

Критерии участия

Критерии включения

• Patients >18 years old
• Patients with a lipoma <5 cm, above the fascia on the trunk, abdomen or extremities

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Columbia University Irving Medical Center — New York

Идентификаторы

NCT: NCT06903208 · AAAV2254

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗