Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride
Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride: an Exploratory Study
West Virginia University
20 participants
May 8, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- At least one clinically diagnosed subcutaneous lipoma
Exclusion Criteria7
- 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
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Interventions
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).
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).
Locations(1)
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NCT06820164