Ultrasound-Guided Emulsification Therapy in the Clinical Treatment of Subcutaneous Lipomas

NCT07797270 | Not Yet Recruiting DMC

• 1 other identifier: S2026-634-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background:Lipomas are the most common benign soft tissue tumors, traditionally treated by open surgical excision. However, open surgery is associated with relatively large incisions, prolonged recovery, and visible scarring. While liposuction offers a less invasive alternative, it often achieves unsatisfactory clearance rates for lipomas with significant fibrotic components, leading to higher recurrence rates. Study Objective:This study aims to investigate the safety and efficacy of CUSA in the minimally invasive treatment of lipomas. Study Methods:this is a single-center, prospective clinical study. A total of 30 eligible patients with clinically diagnosed lipomas scheduled for surgical treatment will be enrolled. All participants will undergo minimally invasive tumor resection using the CUSA system. The primary outcome measure is tumor clearance rate .Secondary outcome measures include operation time, intraoperative blood loss, postoperative pain score, complication rate, recurrence rate, cosmetic outcome, and patient satisfaction. Patients will be followed up for 6 months after treatment. Study Significance:The results of this study will provide evidence-based clinical support for the application of CUSA in the minimally invasive treatment of lipomas, particularly for lesions with abundant fibrotic components, and may help optimize treatment strategies and improve patient outcomes.

Conditions

Lipoma

Keywords

Cavitron Ultrasonic Surgical Aspirator; Minimally invasive surgical procedures; Lipoma

Outcome Measures

Primary Outcomes (1)

• Complete resection rate of lipoma

  Proportion of patients with complete resection of lipoma confirmed by postoperative ultrasound or pathological examination.

  Within 1 week after surgery

Study Arms (1)

CUSA Group

EXPERIMENTAL

All enrolled patients with clinically diagnosed lipoma will undergo minimally invasive tumor resection using the Cavitron Ultrasonic Surgical Aspirator (CUSA) system through a small incision.

Device: CUSA Minimally Invasive Resection

Interventions

CUSA Minimally Invasive Resection DEVICE

CUSA Minimally Invasive Resection

CUSA Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Aged 18 to 60 years; 2. Subcutaneous lipoma confirmed by ultrasound and needle biopsy pathology; 3. Maximum diameter of the lipoma greater than 1 cm; 4. Lipoma located on the trunk, extremities, or neck (excluding the head and face); 5. Lipoma located in the subcutaneous fat layer with a safe distance from the skin and deep tissues; 6. Patients with explicit demand for minimally invasive and cosmetic treatment; 7. Voluntarily participate in the study and sign the informed consent form; 8. Willing to cooperate with preoperative examinations, intraoperative procedures, and postoperative follow-up.

You may not qualify if:

• Coagulation dysfunction or currently receiving anticoagulant therapy;
• Lipoma located in the head and face or within the muscle layer;
• Atypical lipoma or liposarcoma indicated by needle biopsy pathology;
• Ulceration, redness, swelling, or infection of the skin overlying the lipoma;
• Pregnant or lactating women;
• Severe dysfunction of vital organs such as the heart, liver, or kidney;
• Severe mental illness or cognitive impairment;
• Previous history of surgery or radiotherapy at the same site;
• Currently participating in other clinical studies. -

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Related Publications (5)

• Sun Y, Wang Q, Xie H. Minimally Invasive Removal of Frontal Lipoma with Endoscope. Aesthetic Plast Surg. 2026 Feb;50(3):830-838. doi: 10.1007/s00266-025-05293-x. Epub 2025 Oct 10.

  PMID: 41073791 BACKGROUND

• Ahmad N, Bakhshi SK, Shamim MS. Use of ultrasonic aspirator for CNS tumour resection. J Pak Med Assoc. 2021 Jul;71(7):1904-1906.

  PMID: 34410273 BACKGROUND

• Chen CY, Fang QQ, Wang XF, Zhang MX, Zhao WY, Shi BH, Wu LH, Zhang LY, Tan WQ. Madelung's Disease: Lipectomy or Liposuction? Biomed Res Int. 2018 Feb 21;2018:3975974. doi: 10.1155/2018/3975974. eCollection 2018.

  PMID: 29682541 BACKGROUND

• Cosgrave C, Abbas S, Alexander S. Large bleeding duodenal lipoma. Gastrointest Endosc. 2024 Jul;100(1):153-155. doi: 10.1016/j.gie.2023.12.030. Epub 2023 Dec 25. No abstract available.

  PMID: 38151135 BACKGROUND

• Yee EJ, Stewart CL, Clay MR, McCarter MM. Lipoma and Its Doppelganger: The Atypical Lipomatous Tumor/Well-Differentiated Liposarcoma. Surg Clin North Am. 2022 Aug;102(4):637-656. doi: 10.1016/j.suc.2022.04.006.

  PMID: 35952693 BACKGROUND

MeSH Terms

Conditions

Lipoma

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Yukun Luo, Doctor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yukun Luo, Doctor

CONTACT

133 1137 3556; lyk301@163.com

Mingbo Zhang, Doctor

CONTACT

135 5274 4805; owsifanduizhe@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Ultrasound Diagnostics, The First Medical Center of Chinese PLA General Hospital

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share