Can sound waves dissolve breast lumps without surgery?
NCT ID NCT07797257
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This study tests whether ultrasound-guided emulsification therapy can safely and effectively remove benign breast nodules. The technique uses ultrasonic energy to break up the nodule tissue, which is then suctioned out, potentially leaving surrounding breast tissue unharmed. Researchers will enroll 30 women with benign breast nodules and follow them for 6 months to measure complete removal, pain, complications, cosmetic results, and satisfaction. The goal is to see if this approach can offer a less invasive alternative to traditional surgery with better cosmetic outcomes and faster recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ultrasound-guided emulsification therapy using a CUSA device to break up and aspirate benign breast nodule tissue
- What this could lead to
- If it works, this could offer women with benign breast nodules a minimally invasive option that preserves breast shape, reduces scarring, and shortens recovery time compared to traditional surgery.
- What could go wrong
- This is a small, early-stage study with only 30 participants, so results may not apply broadly. Risks include incomplete removal, bleeding, skin injury, or postoperative pain, and the technique's long-term safety and recurrence rates are not yet established.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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. \- Exclusion Criteria: 1. Coagulation dysfunction (platelet count \< 80×10⁹/L, PT prolongation \> 3 s, APTT prolongation \> 10 s) or currently receiving anticoagulant therapy (aspirin, warfarin, clopidogrel, etc.); 2. Malignant or suspiciously malignant findings on core needle biopsy pathology; 3. BI-RADS category 4 or above; 4. Coarse calcification within the nodule (low efficiency of ultrasonic emulsification); 5. Pregnant or lactating women; 6. Nodule located directly beneath the nipple or closely adjacent to the opening of major lactiferous ducts; 7. Severe dysfunction of vital organs such as the heart, liver, or kidney; 8. Severe mental illness or cognitive impairment that prevents cooperation with the procedure and follow-up; 9. Previous history of ipsilateral breast surgery or radiotherapy; 10. Currently participating in other clinical studies of drugs or medical devices. -
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.