LipomaNCT06903208
RFA for Superficial Lipomas
A study testing STARMed VIVA Combo RF System in people with Lipoma, run by Columbia University at 1 site in United States.
Trial summary
Lipomas are non-cancerous growths of fatty tissue that develop under the skin in approximately 1 in 1000 people, though this number may be higher. While rarely symptomatic, they often cause emotional distress due to the unappealing appearance of the mass. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lipoma
- What is being tested?
- STARMed VIVA Combo RF System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >18 years old
- Patients with a lipoma <5 cm, above the fascia on the trunk, abdomen or extremities
Who cannot join
- Lipomas of the face or neck
- Angiolipomas (identified on exam as a firm, mobile, occasionally discolored mass)
- Patients with history of hereditary retinoblastoma, Li-Fraumeni syndrome, familial adenomatous polyposis, neurofibromatosis, tuberous sclerosis and Werner syndrome
- A history of exposure to herbicides, arsenic and dioxin
- A history of radiation treatment for other cancers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Katherine Fischkoff, MD, 212-342-1734, kf2403@cumc.columbia.edu
About this study
Official title: Radiofrequency Ablation as a Scar-free, Non-operative Approach to Treatment of Superficial Lipomas
Lipomas are non-cancerous growths of fatty tissue that develop under the skin in approximately 1 in 1000 people, though this number may be higher. While rarely symptomatic, they often cause emotional distress due to the unappealing appearance of the mass. Treatment of unsightly lipomas is excision with local anesthetic in the office or with sedation in the operating room. The recovery period is short and the procedure is low risk; however, the result of the operation is a visible scar over the site of the lipoma. Many patients defer surgical excision because excision of a lipoma is a cosmetic procedure, but the aesthetic outcome is undesirable.
Radiofrequency ablation (RFA) is a technique that applies heat generated by a high frequency, alternating current to soft tissue. The hyperthermia produced by the current causes tissue necrosis that ablates the tissue into which the energy is directed. RFA has been successfully applied to thyroid nodules, pancreatic lesions, esophageal dysplasia and liver tumors. However, the manufacturers of the RFA technology have been focused on its application in pre-malignant and malignant lesions and have not yet considered its application to benign tumors. This study will test the success of RFA for superficial lipomas as a non-surgical option for treatment.
- Conditions
- Lipoma
- Being tested
- STARMed VIVA Combo RF System
- Keywords
- lipoma, ablation, fatty tissue, fatty tumor, scarring, minimally invasive
- Medical subject headings
- Lipoma, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STARMed VIVA Combo RF SystemDevice
Also called Radiofrequency Ablation (RFA)
RFA is a kind of treatment that uses a long thin needle, called a probe, to melt the lipoma. After numbing the skin with a local anesthetic, using an ultrasound machine as a guide, the study surgeon will insert the probe into the center of the lipoma. The probe will then deliver heat to the lipoma, melting it. The ultrasound is a machine which bounces sound waves to create an image that the study doctor sees on a screen. These ultrasound images will help the study surgeon to accurately guide the probe to the correct location of the lipoma. Once the lipoma is melted, the study surgeon will aspirate any residual liquid out.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation (RFA) | Experimental | As this is a single-arm study, all patients enrolled will get the study procedure/treatment of radiofrequency ablation (RFA). Receives: Device: STARMed VIVA Combo RF System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Patient satisfaction will be measured by self-reporting on a Likert scale asking whether they would recommend the procedure: "On a scale of 1 (would not recommend) to 5 (would highly recommend), how likely would you be to recommend RFA treatment of a lipoma to a friend?"
Measured: 1 month, 6 months and 12 months post-procedure
Change in Lesion Volume
Lesion volume change from baseline to 1 year.
Measured: Baseline, 1 month, 6 months and 12 months post-procedure
Secondary outcomes (1)
Complication rate
Number of any complications after treatment.
Measured: 1 month, 6 months and 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start2 Apr 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipomaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Fischkoff, Columbia University
- Investigators
- Katherine Fischkoff, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903208
- Sponsor's protocol ID
- AAAV2254
- Status last verified
- Aug 2026
- First submitted
- 24 Mar 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation as a Scar-free, Non-operative Approach to Treatment of Superficial Lipomas
- ClinicalTrials.gov ID
- NCT06903208
- Acronym / sponsor ID
- AAAV2254
- Conditions
- Lipoma
- Keywords
- lipoma, ablation, fatty tissue, fatty tumor, scarring, minimally invasive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lipomas are non-cancerous growths of fatty tissue that develop under the skin in approximately 1 in 1000 people, though this number may be higher. While rarely symptomatic, they often cause emotional distress due to the unappealing appearance of the mass. Treatment of unsightly lipomas is excision with local anesthetic in the office or with sedation in the operating room. The recovery period is short and the procedure is low risk; however, the result of the operation is a visible scar over the site of the lipoma. Many patients defer surgical excision because excision of a lipoma is a cosmetic procedure, but the aesthetic outcome is undesirable.
Radiofrequency ablation (RFA) is a technique that applies heat generated by a high frequency, alternating current to soft tissue. The hyperthermia produced by the current causes tissue necrosis that ablates the tissue into which the energy is directed. RFA has been successfully applied to thyroid nodules, pancreatic lesions, esophageal dysplasia and liver tumors. However, the manufacturers of the RFA technology have been focused on its application in pre-malignant and malignant lesions and have not yet considered its application to benign tumors. This study will test the success of RFA for superficial lipomas as a non-surgical option for treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation (RFA) | Experimental | Device: STARMed VIVA Combo RF SystemAs this is a single-arm study, all patients enrolled will get the study procedure/treatment of radiofrequency ablation (RFA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients >18 years old
- Patients with a lipoma <5 cm, above the fascia on the trunk, abdomen or extremities
Key exclusion criteria (5 listed)
- Lipomas of the face or neck
- Angiolipomas (identified on exam as a firm, mobile, occasionally discolored mass)
- Patients with history of hereditary retinoblastoma, Li-Fraumeni syndrome, familial adenomatous polyposis, neurofibromatosis, tuberous sclerosis and Werner syndrome
- A history of exposure to herbicides, arsenic and dioxin
- A history of radiation treatment for other cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STARMed VIVA Combo RF SystemAlso: Radiofrequency Ablation (RFA)RFA is a kind of treatment that uses a long thin needle, called a probe, to melt the lipoma. After numbing the skin with a local anesthetic, using an ultrasound machine as a guide, the study surgeon will insert the probe into the center of the lipoma. The probe will then deliver heat to the lipoma, melting it. The ultrasound is a machine which bounces sound waves to create an image that the study doctor sees on a screen. These ultrasound images will help the study surgeon to accurately guide the probe to the correct location of the lipoma. Once the lipoma is melted, the study surgeon will aspirate any residual liquid out. | Device | Radiofrequency ablation (RFA) |
Primary outcome
Patient Satisfaction
Time frame: 1 month, 6 months and 12 months post-procedure
Patient satisfaction will be measured by self-reporting on a Likert scale asking whether they would recommend the procedure: "On a scale of 1 (would not recommend) to 5 (would highly recommend), how likely would you be to recommend RFA treatment of a lipoma to a friend?"
Change in Lesion Volume
Time frame: Baseline, 1 month, 6 months and 12 months post-procedure
Lesion volume change from baseline to 1 year.
1 secondary outcome
Complication rate
Time frame: 1 month, 6 months and 12 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Columbia University Irving Medical Center
New York, United States
Katherine Fischkoff, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STARMed VIVA Combo RF System in people with Lipoma, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: 1 month, 6 months and 12 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.