lipoma
Conditions
Interventions
Lipoma:high intensity focused ultrasound
Dorsocervical fat pad hypertrophy:high intensity focused ultrasound
Sponsors
Shanghai Ninth Peoples Hospital,Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years (inclusive), both genders. 2. Diagnosed by plastic surgery clinical physical examination combined with ultrasound/MRI, with clear lesion boundaries, and measurable maximum diameter, thickness, area, and volume. The lesion area is calculated as the maximum diameter multiplied by the maximum perpendicular diameter on imaging. Specifically, the dorsocervical fat pad hypertrophy area is 20-120 cm^2, and the lipoma area is 1-16 cm^2, both of which must be completely coverable within a single planned treatment area: (1) Dorsocervical fat pad hypertrophy: adipose accumulation with fascial hyperplasia in the posterior cervical C7-T1 region; (2) Lipoma: solitary subcutaneous lipoma, with no malignant tendency indicated by ultrasound/MRI. 3. Intact skin at the lesion site without ulceration, infection, ulcers, eczema, or other skin lesions. 4. No severe underlying diseases, with essentially normal blood routine, liver and kidney function, and coagulation function. 5. Voluntary participation in this study, fully understanding the study contents, signing the written informed consent form, and capable of cooperating to complete the entire treatment course and follow-up. 6. No prior treatment for the specified lesion within the past 3 months.
Exclusion criteria
Exclusion criteria: 1.Unclear nature of the lesion, suspected malignancy by ultrasound/MRI, or requiring puncture biopsy to rule out malignancy. 2.The lesion is adjacent to vital blood vessels, nerves, or organs, rendering precise ultrasound targeting and focusing unfeasible and posing treatment risks. 3.Presence of severe underlying diseases such as cardiac, hepatic, renal, cerebrovascular, or coagulation disorders, or uncontrolled metabolic diseases such as diabetes mellitus or hyperlipidemia. 4.Pregnant or lactating women, or those planning pregnancy during the study period. 5.Allergic to treatment-related consumables such as ultrasound coupling agent or medical gel. 6.Presence of electronic implants such as cardiac pacemakers or cochlear implants, or metal implants at the lesion site. 7.Previous history of focused ultrasound therapy, or history of surgery, radiotherapy, or laser therapy at the lesion site. 8.Patients with psychiatric disorders or cognitive impairment, with poor compliance, who are unable to complete treatment and follow-up. 9.Currently participating in other clinical studies, or having used drugs that affect tissue repair within the past 3 months. 10.Obesity (BMI = 30 kg/m²) or malnutrition, which may affect lesion tissue repair.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment completion rate and tolerability of treatment parameters;Percentage change in target lesion area or volume from baseline;Incidence of treatment-related adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory safety parameters;appearance satisfaction score;Recurrence or re-enlargement of lesion;Quality of life score; | — |
Countries
China
Contacts
Public ContactWang Chen
Shanghai Ninth Peoples Hospital,Shanghai JiaoTong University School of Medicine
Outcome results
None listed