Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride

West Virginia University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Lipoma

Treatments: Drug: Warmed Sodium Chloride Injection; Drug: Cooled Sodium Chloride Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06820164

2410045096

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Cooled Sodium Chloride Injection

Experimental group

Description:

Injection of a solution containing sterile, cooled 0.9% sodium chloride and 1% lidocaine with epinephrine (1:100,000). Each patient will receive a volume of solution equal to three times the estimated volume of the lipoma; the first cc of the injection will be lidocaine with epinephrine, and the remainder will be sterile normal saline. The solution will be cooled using an ice/saline bath at -1°C. Following the injection, the lipoma will be gently massaged for one minute to distribute the saline evenly.

Treatment:

Drug: Cooled Sodium Chloride Injection

Warmed Sodium Chloride Injection

Experimental group

Description:

Injection of a solution containing sterile, warm 0.9% sodium chloride and 1% lidocaine with epinephrine (1:100,000). Each patient will receive a volume of solution equal to three times the estimated volume of the lipoma; the first cc of the injection will be lidocaine with epinephrine, and the remainder will be sterile normal saline. The saline vials and syringes will both be warmed using a Thermo Fisher Scientific dry bath calibrated to 55°C; a precise temperature stability will be achieved by using a mercury thermometer. Following the injection, the lipoma will be gently massaged for one minute to distribute the saline evenly.

Treatment:

Drug: Warmed Sodium Chloride Injection