Benign Breast NodulesNCT07797257
Ultrasound-Guided Emulsification Therapy in the Clinical Treatment of Benign Breast Nodules
A study testing CUSA Minimally Invasive Resection in people with Benign Breast Nodules, run by Chinese PLA General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Benign Breast Nodules
- What is being tested?
- CUSA Minimally Invasive Resection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. 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.
- -
Who cannot join
- 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;
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- 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. -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ultrasound-Guided Emulsification Therapy for Benign Breast Nodules: A Clinical Study
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.
Read more
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.
Read the detailed description
New Technology： Ultrasound-guided emulsification therapy is an emerging minimally invasive technique that, under real-time ultrasound guidance, utilizes ultrasonic energy to emulsify benign breast nodule tissue, followed by immediate aspiration of the emulsified tissue through a small puncture channel. Compared with conventional open surgical excision, vacuum-assisted excision, and thermal ablation (radiofrequency, microwave, or laser), ultrasound-guided emulsification therapy offers the advantages of real-time intraoperative ultrasound monitoring, precise nodule targeting, minimal damage to surrounding normal breast parenchyma and ducts, effective fragmentation and clearance of nodule tissue, good intraoperative hemostasis, no thermal injury to the skin or nipple-areola complex, the ability to operate through a tiny puncture point, favorable cosmetic outcomes, preservation of breast shape, and rapid postoperative recovery. However, its clinical safety and efficacy in the minimally invasive treatment of benign breast nodules remain to be systematically validated.
Sample Size Calculation (30 cases)：
This is a single-center, prospective, single-arm clinical study with the primary outcome of nodule clearance rate after ultrasound-guided emulsification therapy for benign breast nodules. According to previous literature, the complete clearance rate of conventional open surgical excision is approximately 95%-100%, while vacuum-assisted excision achieves a complete clearance rate of 85%-95% and thermal ablation reports a complete ablation rate of 80%-95% for benign breast nodules. This study assumes that the nodule clearance rate of ultrasound-guided emulsification therapy is no less than 90%. With a two-sided significance level α = 0.05 and a margin of error d = 10%, the sample size is calculated using the binomial distribution formula:
n = Z²α/2 × p(1-p) / d² Substituting p = 0.90, Zα/2 = 1.96, and d = 0.10 yields n ≈ 34.6. Accounting for an approximate 10% loss to follow-up, a total of 30 patients will be enrolled. In addition, as an exploratory study, a sample size of 30 is sufficient to assess the safety and preliminary efficacy of ultrasound-guided emulsification therapy and is comparable to the sample sizes of similar minimally invasive breast studies (20-40 cases) reported in the literature.
Statistical Analysis Methods： Analysis sets: The full analysis set (FAS), including all patients who received ultrasound-guided emulsification therapy and completed at least one postoperative assessment, will be used for efficacy analysis. The safety set (SS), including all patients who received ultrasound-guided emulsification therapy, will be used for safety analysis.
Descriptive statistics: Normally distributed continuous variables are presented as mean ± standard deviation (x̄ ± s); non-normally distributed continuous variables are presented as median (interquartile range) [M (P25, P75)]; categorical variables are presented as frequency (percentage) [n (%)].
Primary outcome analysis: The nodule clearance rate is presented as a point estimate with a 95% confidence interval (95% CI), calculated using the binomial distribution method.
Secondary outcome analysis: Continuous variables such as operation time, intraoperative blood loss, and postoperative pain score (VAS) are analyzed using descriptive statistics; categorical variables such as complication rate and recurrence rate are presented as frequency (percentage) with 95% CI.
Survival analysis: The postoperative recurrence-free survival rate is analyzed using the Kaplan-Meier method, and survival curves are plotted.
Statistical software and significance level: Statistical analysis is performed using SPSS 26.0 (IBM Corp., Armonk, NY, USA) or R 4.x software. All tests are two-sided, and P < 0.05 is considered statistically significant.
- Conditions
- Benign Breast Nodules
- Being tested
- CUSA Minimally Invasive Resection
- Keywords
- Benign Breast Nodules, Minimally invasive surgical procedures, Cavitron Ultrasonic Surgical Aspirator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUSA Minimally Invasive ResectionDevice
CUSA Minimally Invasive Resection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CUSA Minimally Invasive Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete resection rate of benign breast nodules
Proportion of patients with complete resection of benign breast nodules confirmed by postoperative ultrasound or pathological examination.
Measured: Within 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Benign Breast NodulesStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yukun Luo, Chinese PLA General Hospital
- Investigators
- Yukun Luo, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797257
- Sponsor's protocol ID
- S2026-633-01
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31120790Stachs 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.
PubMed 31554551
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Emulsification Therapy for Benign Breast Nodules: A Clinical Study
- ClinicalTrials.gov ID
- NCT07797257
- Acronym / sponsor ID
- S2026-633-01
- Conditions
- Benign Breast Nodules
- Keywords
- Benign Breast Nodules, Minimally invasive surgical procedures, Cavitron Ultrasonic Surgical Aspirator
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
New Technology： Ultrasound-guided emulsification therapy is an emerging minimally invasive technique that, under real-time ultrasound guidance, utilizes ultrasonic energy to emulsify benign breast nodule tissue, followed by immediate aspiration of the emulsified tissue through a small puncture channel. Compared with conventional open surgical excision, vacuum-assisted excision, and thermal ablation (radiofrequency, microwave, or laser), ultrasound-guided emulsification therapy offers the advantages of real-time intraoperative ultrasound monitoring, precise nodule targeting, minimal damage to surrounding normal breast parenchyma and ducts, effective fragmentation and clearance of nodule tissue, good intraoperative hemostasis, no thermal injury to the skin or nipple-areola complex, the ability to operate through a tiny puncture point, favorable cosmetic outcomes, preservation of breast shape, and rapid postoperative recovery. However, its clinical safety and efficacy in the minimally invasive treatment of benign breast nodules remain to be systematically validated.
Sample Size Calculation (30 cases)：
This is a single-center, prospective, single-arm clinical study with the primary outcome of nodule clearance rate after ultrasound-guided emulsification therapy for benign breast nodules. According to previous literature, the complete clearance rate of conventional open surgical excision is approximately 95%-100%, while vacuum-assisted excision achieves a complete clearance rate of 85%-95% and thermal ablation reports a complete ablation rate of 80%-95% for benign breast nodules. This study assumes that the nodule clearance rate of ultrasound-guided emulsification therapy is no less than 90%. With a two-sided significance level α = 0.05 and a margin of error d = 10%, the sample size is calculated using the binomial distribution formula:
n = Z²α/2 × p(1-p) / d² Substituting p = 0.90, Zα/2 = 1.96, and d = 0.10 yields n ≈ 34.6. Accounting for an approximate 10% loss to follow-up, a total of 30 patients will be enrolled. In addition, as an exploratory study, a sample size of 30 is sufficient to assess the safety and preliminary efficacy of ultrasound-guided emulsification therapy and is comparable to the sample sizes of similar minimally invasive breast studies (20-40 cases) reported in the literature.
Statistical Analysis Methods： Analysis sets: The full analysis set (FAS), including all patients who received ultrasound-guided emulsification therapy and completed at least one postoperative assessment, will be used for efficacy analysis. The safety set (SS), including all patients who received ultrasound-guided emulsification therapy, will be used for safety analysis.
Descriptive statistics: Normally distributed continuous variables are presented as mean ± standard deviation (x̄ ± s); non-normally distributed continuous variables are presented as median (interquartile range) [M (P25, P75)]; categorical variables are presented as frequency (percentage) [n (%)].
Primary outcome analysis: The nodule clearance rate is presented as a point estimate with a 95% confidence interval (95% CI), calculated using the binomial distribution method.
Secondary outcome analysis: Continuous variables such as operation time, intraoperative blood loss, and postoperative pain score (VAS) are analyzed using descriptive statistics; categorical variables such as complication rate and recurrence rate are presented as frequency (percentage) with 95% CI.
Survival analysis: The postoperative recurrence-free survival rate is analyzed using the Kaplan-Meier method, and survival curves are plotted.
Statistical software and significance level: Statistical analysis is performed using SPSS 26.0 (IBM Corp., Armonk, NY, USA) or R 4.x software. All tests are two-sided, and P < 0.05 is considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CUSA Group | Experimental | Device: CUSA Minimally Invasive ResectionAll 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. 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.
- -
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CUSA Minimally Invasive ResectionCUSA Minimally Invasive Resection | Device | CUSA Group |
Primary outcome
Complete resection rate of benign breast nodules
Time frame: Within 1 week after surgery
Proportion of patients with complete resection of benign breast nodules confirmed by postoperative ultrasound or pathological examination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 31120790Ward 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.
- Background: PubMed 31554551Stachs 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yukun Luo principal investigator
Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing CUSA Minimally Invasive Resection in people with Benign Breast Nodules, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yukun Luo, Doctor (+86 133 1137 3556 ext. 010-66937394, lyk301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete resection rate of benign breast nodules (time frame: Within 1 week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07797257, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.