Actively Recruiting
Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride: an Exploratory Study
Led by West Virginia University · Updated on 2026-04-29
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Lipomas are common benign tumors made of mature fat tissue, often removed for cosmetic reasons or because they press on nearby structures. This research explores subcutaneous injections of cooled normal saline as a possible nonsurgical treatment for lipomas. The study also includes an additional group to assess warmed normal saline injections, aiming to find a more comfortable alternative to fat-freezing devices applied on the skin. Participants will receive injections directly into their lipomas using either cooled or warmed sterile sodium chloride mixed with lidocaine and epinephrine. The volume of the injected solution will be three times the estimated lipoma size. After the injection, the area will be gently massaged to distribute the solution evenly. This study includes multiple treatments spaced about four weeks apart. During the study, researchers will monitor pain and redness fifteen minutes after each injection, as well as changes in lipoma size after multiple treatments and up to twelve weeks following the last injection. Participants may receive up to four treatments, and the study is designed to evaluate safety and effectiveness over this period. The total participation duration varies, with ongoing assessments throughout the treatment and follow-up phases.
CONDITIONS
Brief Title
Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least one clinically diagnosed subcutaneous lipoma
- Age 18 years or older
You will not qualify if you...
- Unable to give informed consent
- Lipoma located on the face
- Lipomas located subfascial or within deep tissue such as intramuscular lipomas
- Lipomas larger than 10 cm in diameter or fat deposits exceeding 500 mL in volume
- Rapidly growing lipomas
- Lipomas with abnormal ultrasound findings like complex patterns or multilobulated appearance
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks with 4-week intervals between treatments
Participants receive up to four subcutaneous injections of cooled or warmed sodium chloride into the lipoma, with each injection followed by gentle massage to distribute the solution evenly.
4 treatment visits spaced 4 weeks apart
Duration - 12 weeks following the fourth treatment
Participants are monitored for changes in lipoma size and any post-injection effects for 12 weeks after the final treatment.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
West Virginia University
Morgantown, West Virginia, United States, 26505
Actively Recruiting
Research Team
J
Jessica Patterson, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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