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

NCT07797257 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-09-01

No results posted yet for this study

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

Interventions

DEVICE

CUSA Minimally Invasive Resection

CUSA Minimally Invasive Resection

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Yukun Luo · Chinese PLA General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-10-31
Completion
2028-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07797257 on ClinicalTrials.gov