drugset / Trial / NCT06820164

Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride

NCT06820164

Phase 1/2 Recruiting 20 enrolled West Virginia University
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-05-08
Primary completion
2027-01
Completion
2027-01

Drugs

EvaluationDrugModalityDoseRoute
Subject sodium chloride Unknown 0.9 % Other
Background Epinephrine Other / unclassified Other
Background Lidocaine Other / unclassified 1 % Other

Indications