A Phase 1/2 interventional study of Cooled Sodium Chloride Injection and Warmed Sodium Chloride Injection in Lipoma, sponsored by West Virginia University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by West Virginia University · Phase 1/2, Interventional, and Treatment
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.
22 studies on the registry are indexed under Lipoma; 6 are open to participants now.
This study's planned enrollment of 20 is below the median of 30 across 17 interventional studies indexed under Lipoma.
Browse Lipoma studies →West Virginia University is the lead sponsor of 157 studies on the registry; 36 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Cooled 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.
Drug: 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, cooled 0.9% sodium chloride and 1% lidocaine with epinephrine (1:100,000).
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).
Post-Injection Pain (First Treatment)
Pain is assessed using a scale of 0-10 reported by the patient, with 0 being no pain and 10 being the worst pain ever experienced.
Time frame: 15 minutes post injection (treatment)
Post-Injection Pain (Second Treatment)
Pain is assessed using a scale of 0-10 reported by the patient, with 0 being no pain and 10 being the worst pain ever experienced.
Time frame: 15 minutes post injection (treatment)
Post-Injection Pain (Third Treatment)
Pain is assessed using a scale of 0-10 reported by the patient, with 0 being no pain and 10 being the worst pain ever experienced.
Time frame: 15 minutes post injection (treatment)
Post-Injection Pain (Forth Treatment)
Pain is assessed using a scale of 0-10 reported by the patient, with 0 being no pain and 10 being the worst pain ever experienced.
Time frame: 15 minutes post injection (treatment)
Post-injection erythema (First Treatment)
Post-injection erythema is assessed using a scale of 0-4 as per the Clinical Erythema Assessment grading scale with: 0 = clear, 1 = almost clear, 2 = mild erythema, 3 = moderate erythema, and 4 = severe erythema. The higher score indicates a worse outcome.
Time frame: 15 minutes post injection (treatment)
Post-injection erythema (Second Treatment)
Post-injection erythema is assessed using a scale of 0-4 as per the Clinical Erythema Assessment grading scale with: 0 = clear, 1 = almost clear, 2 = mild erythema, 3 = moderate erythema, and 4 = severe erythema. The higher score indicates a worse outcome.
Time frame: 15 minutes post injection (treatment)
Post-injection erythema (Third Treatment)
Post-injection erythema is assessed using a scale of 0-4 as per the Clinical Erythema Assessment grading scale with: 0 = clear, 1 = almost clear, 2 = mild erythema, 3 = moderate erythema, and 4 = severe erythema. The higher score indicates a worse outcome.
Time frame: 15 minutes post injection (treatment)
Post-injection erythema (Forth Treatment)
Post-injection erythema is assessed using a scale of 0-4 as per the Clinical Erythema Assessment grading scale with: 0 = clear, 1 = almost clear, 2 = mild erythema, 3 = moderate erythema, and 4 = severe erythema. The higher score indicates a worse outcome.
Time frame: 15 minutes post injection (treatment)
Change in Lipoma Size (Second Treatment)
Change in Lipoma Size from the First Treatment (Baseline) to the Second Treatment. There is a 4 week interval between each treatment. Lipoma size is assessed using approximate lipoma area (cm × cm) determined by ultrasound, with the final percentage change being the following quotient: \[(final area - initial area) ÷ initial area\] × 100.
Time frame: Baseline to Second Treatment (4-week interval between treatments)
Change in Lipoma Size (Third Treatment)
Change in Lipoma Size from the First Treatment (Baseline) to the Third Treatment. Lipoma size is assessed using approximate lipoma area (cm × cm) determined by ultrasound, with the final percentage change being the following quotient: \[(final area - initial area) ÷ initial area\] × 100.
Time frame: Baseline to Third Treatment (4-week interval between treatments)
Change in Lipoma Size (Forth Treatment)
Change in Lipoma Size from the First Treatment (Baseline) to the Forth Treatment. Lipoma size is assessed using approximate lipoma area (cm × cm) determined by ultrasound, with the final percentage change being the following quotient: \[(final area - initial area) ÷ initial area\] × 100.
Time frame: Baseline to Forth Treatment (4-week interval between treatments)
Change in Lipoma Size (12 weeks following the Fourth Treatment)
Change in Lipoma Size from the First Treatment (Baseline) to 12 weeks following the Fourth Treatment. Lipoma size is assessed using approximate lipoma area (cm × cm) determined by ultrasound, with the final percentage change being the following quotient: \[(final area - initial area) ÷ initial area\] × 100.
Time frame: From Baseline to 12 weeks following the Fourth Treatment
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.