Breast FibroadenomaHIFU-003NCT03044054
Treatment of Breast Fibroadenoma Targeted Tissue With HIFU
A study testing ECHOPULSE in people with Breast Fibroadenoma, run by Theraclion at 4 sites in United States.
Trial summary
This study evaluates the efficacy and the safety of the HIFU for the treatment of breast fibroadenoma. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Fibroadenoma
- What is being tested?
- ECHOPULSE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2017to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients 18 years or older diagnosed with breast fibroadenoma and presenting at least one fibroadenoma.
- Diagnosis of fibroadenoma must be based on:
- Clinical examination
- Ultrasound image alone for patients under 35 years old. For women older than 35 years, a mammogram will be performed in addition to ultrasound. The BI-RADS score of this mammogram must be 2 or 3. BI-RADS score of 4 is eligible if biopsy indicates fibroadenoma with concordance.
- Histologic confirmation by core needle biopsy.
- Patient is a candidate for the surgery.
Show all 14Show fewer
- The fibroadenoma treatment volume must be at least 5 mm and no more than 26 mm from the skin. This criterion should be evaluated immediately prior treatment, once the breast is immobilized and potentially compressed.
- The rib cage should not be in the prefocal ultrasound path or behind the target fibroadenoma (minimum distance from the posterior wall of the fibroadenoma must be at least 10 mm). This criterion shall be evaluated immediately prior to treatment, once breast is immobilized and potentially compressed.
- The fibroadenoma is 1 cm or greater at its largest dimension and no less than 7.5 mm in the anterior-posterior dimension (measured by ultrasound). Focal point for HIFU treatment must also be at least 3 mm from any border of the fibroadenoma.
- Patient's fibroadenoma size is greater or equal to 0.2 cc and less than 10 cc in volume (measured by ultrasound on the day of the procedure).
- Fibroadenoma is palpable.
- Pain ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days
- Anxiety ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days
- Patient has signed a written informed consent.
Who cannot join
- Patient is pregnant or nursing.
- Presence of calcified fibroadenoma. Calcification will be determined with mammography. In women > 35 years old, the diagnostic mammogram should be evaluated for calcification. In women ≤ 35 years old, a single view mammogram of the affected breast is sufficient for evaluation of calcification. Women ≤ 35 years old will be excluded based on the findings of calcification on a single view mammogram.
- Patient with history of breast cancer or history of laser or radiation therapy to the target breast.
- Patient with breast implants in the target breast.
- Patient with a breast cyst within the fibroadenoma to be treated.
- Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
- Patient participating in another clinical trial involving an investigational drug, device or biologic.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Virginia Health system
Charlottesville, Virginia, 22903
Bellevue Hospital Center
New York, New York, 10016
New York Columbia University Medical Center
New York, New York, 10032
Montefiore-Einstein Center for Cancer Care
New York, New York
About this study
Official title: Treatment of Breast Fibroadenoma Targeted Tissue With High Intensity Focused Ultrasound (HIFU)
This study evaluates the efficacy and the safety of the HIFU for the treatment of breast fibroadenoma.
Read the detailed description
Echopulse is specially designed, manufactured and CE marked for treating breast fibroadenoma. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.
- Conditions
- Breast Fibroadenoma
- Being tested
- ECHOPULSE
- Keywords
- HIFU
- Medical subject headings
- Fibroadenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECHOPULSEDevice
HIFU Under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| ECHOPULSE | Experimental | ECHOPULSE HIFU Receives: Device: ECHOPULSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level assessment
visual analog scale
Measured: 12 Months
Anxiety level assessment
visual analog scale
Measured: 12 Months
Volume assessment
Ultrasound measurement
Measured: 12 Months
Secondary outcomes (5)
The short (6-item) version of the State-Trait Anxiety Inventory (STAI)
Measured: inclusion visit (V0), Day 2/3, Day 7, 6 months, 12 months
Palpability of the breast fibroadenoma
Physician clinical examination
Measured: inclusion visit (V0), Day 2/3, Day 7, 6 months, 12 months
Freedom from additional procedures for fibroadenoma of the breast
Physician assessment concerning the need of additional procedures
Measured: Day 2/3, Day 7, 6 months, 12 months
Patient satisfaction
Self assessment satisfaction questionnaire
Measured: Month 6 and Months 12
Safety endpoints include adverse events (AEs) and serious adverse events (SAEs) occurring at any time during the trial.
Assessment and capture of adverse events
Measured: Day 0, Day 2/3, Day 7, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study startJan 2017
- Primary completionMar 2026
- Study completionApr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FibroadenomaStudies of the same condition, open and under way.
- 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
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theraclion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michel NUTA, MD, Study director, Theraclion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044054
- Sponsor's protocol ID
- HIFU/FA/003
- Acronym
- HIFU-003
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2017
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Breast Fibroadenoma Targeted Tissue With High Intensity Focused Ultrasound (HIFU)
- ClinicalTrials.gov ID
- NCT03044054
- Acronym / sponsor ID
- HIFU-003 / HIFU/FA/003
- Conditions
- Breast Fibroadenoma
- Keywords
- HIFU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- TheraclionIndustry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2026 (actual)
- Study completion
- Apr 2026 (actual)
- First posted
- 6 Feb 2017 (estimated)
- 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.
This study evaluates the efficacy and the safety of the HIFU for the treatment of breast fibroadenoma.
Detailed description
Echopulse is specially designed, manufactured and CE marked for treating breast fibroadenoma. HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver a large amount of sound energy to a focal point to rapidly induce tissue heating to 85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted area.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECHOPULSE | Experimental | Device: ECHOPULSEECHOPULSE HIFU |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Female patients 18 years or older diagnosed with breast fibroadenoma and presenting at least one fibroadenoma.
- Diagnosis of fibroadenoma must be based on:
- Patient is a candidate for the surgery.
- The fibroadenoma treatment volume must be at least 5 mm and no more than 26 mm from the skin. This criterion should be evaluated immediately prior treatment, once the breast is immobilized and potentially compressed.
- The rib cage should not be in the prefocal ultrasound path or behind the target fibroadenoma (minimum distance from the posterior wall of the fibroadenoma must be at least 10 mm). This criterion shall be evaluated immediately prior to treatment, once breast is immobilized and potentially compressed.
Key exclusion criteria (7 listed)
- Patient is pregnant or nursing.
- Presence of calcified fibroadenoma. Calcification will be determined with mammography. In women > 35 years old, the diagnostic mammogram should be evaluated for calcification. In women ≤ 35 years old, a single view mammogram of the affected breast is sufficient for evaluation of calcification. Women ≤ 35 years old will be excluded based on the findings of calcification on a single view mammogram.
- Patient with history of breast cancer or history of laser or radiation therapy to the target breast.
- Patient with breast implants in the target breast.
- Patient with a breast cyst within the fibroadenoma to be treated.
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 |
|---|---|---|
| ECHOPULSEHIFU Under ultrasound guidance | Device | ECHOPULSE |
Primary outcome
Pain level assessment
Time frame: 12 Months
visual analog scale
Anxiety level assessment
Time frame: 12 Months
visual analog scale
Volume assessment
Time frame: 12 Months
Ultrasound measurement
5 secondary outcomes
The short (6-item) version of the State-Trait Anxiety Inventory (STAI)
Time frame: inclusion visit (V0), Day 2/3, Day 7, 6 months, 12 months
Palpability of the breast fibroadenoma
Time frame: inclusion visit (V0), Day 2/3, Day 7, 6 months, 12 months
Freedom from additional procedures for fibroadenoma of the breast
Time frame: Day 2/3, Day 7, 6 months, 12 months
Patient satisfaction
Time frame: Month 6 and Months 12
Safety endpoints include adverse events (AEs) and serious adverse events (SAEs) occurring at any time during the trial.
Time frame: Day 0, Day 2/3, Day 7, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Fibroadenoma
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Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma: Safety and Cosmetic Outcomes
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ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) - iSono Health
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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. This study is not recruiting at the moment.
Michel NUTA, MD study director
Theraclion
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECHOPULSE in people with Breast Fibroadenoma, run by Theraclion at 4 sites in United States.
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 14 inclusion and 7 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: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level assessment (time frame: 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2026.