Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride

Официальное название

Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride: an Exploratory Study

Обзор

Lipomas are benign tumors composed of mature adipose tissue. While harmless, these are the most common type of soft tissue growths with some patients developing numerous lipomas. Patients often seek removal for cosmesis, or symptoms caused by location and/or compression of surrounding structures. This exploratory study aims to evaluate the effectiveness of subcutaneous injections of cooled normal saline as a treatment option for lipomas. The study will assess whether this technique could serve as a viable alternative to existing treatment options, especially compared to topically applied fat-freezing devices. The Investigators propose that this method may offer a more comfortable nonsurgical option for targeted fat reduction, as the cold temperatures are applied directly to the lipomas. Amendment to Protocol Feb 2026- Including and additional ARM of the study to evaluate the effectiveness of subcutaneous injections of warmed normal saline as a treatment option for lipomas.

Вмешательства

• Препарат Cooled Sodium Chloride Injection
  A 30-gauge, 0.5-inch needle attached to a 3 mL syringe will be used to directly inject the solution transcutaneously into the lipoma. Injection of a solution containing sterile, cooled 0.9% sodium chloride and 1% lidocaine with epinephrine (1:100,000).
• Препарат Warmed Sodium Chloride Injection
  A 30-gauge, 0.5-inch needle attached to a 3 mL syringe will be used to directly inject the solution transcutaneously into the lipoma. Injection of a solution containing sterile, warmed 0.9% sodium chloride and 1% lidocaine with epinephrine (1:100,000).

Первичные конечные точки

• Post-Injection Pain (First Treatment) [Срок оценки: 15 minutes post injection (treatment)]
• Post-Injection Pain (Second Treatment) [Срок оценки: 15 minutes post injection (treatment)]
• Post-Injection Pain (Third Treatment) [Срок оценки: 15 minutes post injection (treatment)]
• Post-Injection Pain (Forth Treatment) [Срок оценки: 15 minutes post injection (treatment)]
• Post-injection erythema (First Treatment) [Срок оценки: 15 minutes post injection (treatment)]
• Post-injection erythema (Second Treatment) [Срок оценки: 15 minutes post injection (treatment)]
• Post-injection erythema (Third Treatment) [Срок оценки: 15 minutes post injection (treatment)]
• Post-injection erythema (Forth Treatment) [Срок оценки: 15 minutes post injection (treatment)]
• Change in Lipoma Size (Second Treatment) [Срок оценки: Baseline to Second Treatment (4-week interval between treatments)]
• Change in Lipoma Size (Third Treatment) [Срок оценки: Baseline to Third Treatment (4-week interval between treatments)]

Критерии участия

Критерии включения

• At least one clinically diagnosed subcutaneous lipoma

Критерии исключения

• Unable to give informed consent
• Participant has a lipoma on the face
• Lipomas located subfascial or within deep tissue (e.g., intramuscular lipomas)
• Lipomas larger than 10 cm in diameter (fat deposits exceeding 500 mL in volume)
• Rapidly growing lipomas
• Lipomas exhibiting abnormal ultrasound findings (e.g., complex hyperechoic patterns, internal heterogeneity, or multilobulated appearance)
• Pregnant women

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• West Virginia University — Morgantown

Идентификаторы

NCT: NCT06820164 · 2410045096

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗