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NCT06820164PHASE1, PHASE2RecruitingAccepts Healthy Volunteers

Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride

West Virginia University

Start Date

5/8/2025

Completion Date

1/1/2027

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * At least one clinically diagnosed subcutaneous lipoma Exclusion Criteria: * 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

Interventions

DRUG

Cooled Sodium Chloride Injection

DRUG

Warmed Sodium Chloride Injection

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Conditions

Lipoma

Locations

West Virginia University

Morgantown, West Virginia 26505

United States