Ultrasound-Guided Emulsification Therapy in the Clinical Treatment of Benign Breast Nodules

NCT07797257 | Not Yet Recruiting DMC

• 1 other identifier: S2026-633-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background： Benign breast nodules are common breast diseases in women, including fibroadenomas, hyperplastic nodules, and other benign lesions. Traditionally, open surgical excision has been the standard treatment, but it is associated with visible scarring, damage to breast shape, prolonged recovery, and high costs. While minimally invasive approaches such as vacuum-assisted excision and thermal ablation (radiofrequency, microwave, laser) have been developed, they still have limitations including intraoperative bleeding, residual lesions, skin injury, and postoperative pain. Ultrasound-guided emulsification therapy is an emerging minimally invasive technique that utilizes ultrasonic energy to emulsify nodule tissue followed by aspiration, offering potential advantages of precise tissue targeting, minimal damage to surrounding normal breast tissue, favorable cosmetic outcomes, and rapid recovery. However, its clinical safety and efficacy in the treatment of benign breast nodules remain to be systematically evaluated. Study Objective： This study aims to investigate the safety and efficacy of ultrasound-guided emulsification therapy in the minimally invasive treatment of benign breast nodules. Study Methods： This is a single-center, prospective clinical study. A total of 30 eligible patients with clinically and pathologically confirmed benign breast nodules scheduled for treatment will be enrolled. All participants will undergo ultrasound-guided emulsification therapy. The primary outcome measure is the nodule clearance rate (complete disappearance rate assessed by postoperative ultrasound). Secondary outcome measures include operation time, intraoperative blood loss, postoperative pain score (VAS), complication rate, recurrence rate at follow-up, cosmetic outcome assessment, 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 ultrasound-guided emulsification therapy in the minimally invasive treatment of benign breast nodules, and may help optimize treatment strategies, preserve breast shape and aesthetics, and improve patient outcomes and quality of life.

Conditions

Benign Breast Nodules

Keywords

Benign Breast Nodules; Minimally invasive surgical procedures; Cavitron Ultrasonic Surgical Aspirator

Outcome Measures

Primary Outcomes (1)

• Complete resection rate of benign breast nodules

  Proportion of patients with complete resection of benign breast nodules confirmed by postoperative ultrasound or pathological examination.

  Within 1 week after surgery

Study Arms (1)

CUSA Group

EXPERIMENTAL

All enrolled patients with clinically and pathologically confirmed benign breast nodules will undergo ultrasound-guided emulsification therapy through a tiny puncture channel under real-time ultrasound monitoring.

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:

• \. Female aged 18 to 60 years; 2. Breast ultrasound indicating BI-RADS category 3; 3. Benign nodule confirmed by ultrasound-guided core needle biopsy pathology; 4. Maximum diameter of the nodule greater than 1 cm; 5. Ultrasound showing well-defined nodule borders with a distance of ≥ 0.5 cm from the skin, pectoralis major muscle, and major lactiferous ducts; 6. Patients with explicit demand for minimally invasive and cosmetic treatment, voluntarily accepting this new technology; 7. Able to understand the study content, voluntarily participate in the study and sign the informed consent form; 8. Willing and able to cooperate with preoperative examinations, intraoperative procedures, and regular postoperative follow-up.

You may not qualify if:

• Coagulation dysfunction (platelet count \< 80×10⁹/L, PT prolongation \> 3 s, APTT prolongation \> 10 s) or currently receiving anticoagulant therapy (aspirin, warfarin, clopidogrel, etc.);
• Malignant or suspiciously malignant findings on core needle biopsy pathology;
• BI-RADS category 4 or above;
• Coarse calcification within the nodule (low efficiency of ultrasonic emulsification);
• Pregnant or lactating women;
• Nodule located directly beneath the nipple or closely adjacent to the opening of major lactiferous ducts;
• Severe dysfunction of vital organs such as the heart, liver, or kidney;
• Severe mental illness or cognitive impairment that prevents cooperation with the procedure and follow-up;
• Previous history of ipsilateral breast surgery or radiotherapy;
• Currently participating in other clinical studies of drugs or medical devices. -

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Related Publications (2)

• Ward RC, Lourenco AP, Mainiero MB. Ultrasound-Guided Breast Cancer Cryoablation. AJR Am J Roentgenol. 2019 Sep;213(3):716-722. doi: 10.2214/AJR.19.21329. Epub 2019 May 23.

  PMID: 31120790 BACKGROUND

• Stachs A, Stubert J, Reimer T, Hartmann S. Benign Breast Disease in Women. Dtsch Arztebl Int. 2019 Aug 9;116(33-34):565-574. doi: 10.3238/arztebl.2019.0565.

  PMID: 31554551 BACKGROUND

Study Officials

• Yukun Luo

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yukun Luo, Doctor

CONTACT

+86 133 1137 3556; lyk301@163.com

Mingbo Zhang, Doctor

CONTACT

+86 135 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