Lipomas Treated with Subcutaneous Injections of Cooled Sodium Chloride

Last updated: March 12, 2025
Sponsor: West Virginia University
Overall Status: Active - Recruiting

Phase

1/2

Condition

Warts

Treatment

Cooled Sodium Chloride Injection

Clinical Study ID

NCT06820164
2410045096
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least one clinically diagnosed subcutaneous lipoma

Exclusion

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

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Cooled Sodium Chloride Injection
Phase: 1/2
Study Start date:
March 01, 2025
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • West Virginia University

    Morgantown, West Virginia 26505
    United States

    Active - Recruiting

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