Recruiting
Phase 1
Phase 2

Cooled Sodium Chloride

Sponsor:

West Virginia University

Code:

NCT06820164

Conditions

Lipoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cooled Sodium Chloride Injection

Warmed Sodium Chloride Injection

Study Details

Brief 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.

Conditions

Lipoma

Study ID

NCT06820164

Start date

May 8, 2025

Status verified date

Apr, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cooled Sodium Chloride Injection

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.

experimental: Warmed Sodium Chloride Injection

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.

Interventions

Cooled Sodium Chloride Injection

A 30-gauge, 0.5-inch needle attached to a 3 mL syringe will be used to directly inject the solution transcutaneously into the lipoma. Injection of a solution containing sterile, cooled 0.9% sodium chloride and 1% lidocaine with epinephrine (1:100,000).

Warmed Sodium Chloride Injection

A 30-gauge, 0.5-inch needle attached to a 3 mL syringe will be used to directly inject the solution transcutaneously into the lipoma. Injection of a solution containing sterile, warmed 0.9% sodium chloride and 1% lidocaine with epinephrine (1:100,000).

Primary outcome measure

  • Post-Injection Pain (First Treatment) [ Time Frame: 15 minutes post injection (treatment) ]
  • Post-Injection Pain (Second Treatment) [ Time Frame: 15 minutes post injection (treatment) ]
  • Post-Injection Pain (Third Treatment) [ Time Frame: 15 minutes post injection (treatment) ]
  • Post-Injection Pain (Forth Treatment) [ Time Frame: 15 minutes post injection (treatment) ]
  • Post-injection erythema (First Treatment) [ Time Frame: 15 minutes post injection (treatment) ]
  • Post-injection erythema (Second Treatment) [ Time Frame: 15 minutes post injection (treatment) ]
  • Post-injection erythema (Third Treatment) [ Time Frame: 15 minutes post injection (treatment) ]
  • Post-injection erythema (Forth Treatment) [ Time Frame: 15 minutes post injection (treatment) ]
  • Change in Lipoma Size (Second Treatment) [ Time Frame: Baseline to Second Treatment (4-week interval between treatments) ]
  • Change in Lipoma Size (Third Treatment) [ Time Frame: Baseline to Third Treatment (4-week interval between treatments) ]
  • Change in Lipoma Size (Forth Treatment) [ Time Frame: Baseline to Forth Treatment (4-week interval between treatments) ]
  • Change in Lipoma Size (12 weeks following the Fourth Treatment) [ Time Frame: From Baseline to 12 weeks following the Fourth Treatment ]

Central Contacts and Locations

Central contacts

Jessica Patterson, MD

304-598-4865jpatter5@hsc.wvu.edu

Locations

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26505

More Information

Sponsor

West Virginia University

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by West Virginia University on 2026-04-29.