NCT06820164 Lipomas Treated With Subcutaneous Injections of Cooled or Warmed Sodium Chloride
| NCT ID | NCT06820164 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | West Virginia University |
| Condition | Lipoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-05-08 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-05-08 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Jessica Patterson, MD
PRINCIPAL INVESTIGATOR
West Virginia University-Dermatology
Frequently Asked Questions
Who can join the NCT06820164 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lipoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06820164 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06820164 currently recruiting?
Yes, NCT06820164 is actively recruiting participants. Contact the research team at jpatter5@hsc.wvu.edu for enrollment information.
Where is the NCT06820164 trial being conducted?
This trial is being conducted at Morgantown, United States.
Who is sponsoring the NCT06820164 clinical trial?
NCT06820164 is sponsored by West Virginia University. The principal investigator is Jessica Patterson, MD at West Virginia University-Dermatology. The trial plans to enroll 20 participants.