About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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);
Trial design
Single group
Treatments tested in this trial
CUSA Minimally Invasive Resection
DeviceCUSA Minimally Invasive Resection
Treatment groups
Trial outcomes
Primary outcomes
Complete resection rate of benign breast nodules
Proportion of patients with complete resection of benign breast nodules confirmed by postoperative ultrasound or pathological examination.
Locations
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