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CompletedNCT02488655Updated Oct 19, 2021

Treatment of Breast Fibroadenoma With FastScan HIFU

An interventional study of Echopulse in Breast Fibroadenoma, sponsored by Theraclion. Completed at 1 site in Bulgaria. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-19.

Sponsored by Theraclion · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

This study evaluates the efficacy of the HIFU for the treatment of breast fibroadenoma with the FastScan version using assessment of patient experience and adverse event reporting.

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.

In a previous european feasibility study performed at 4 sites (France and Bulgaria), 51 fibroadenomas in 42 patients were treated. The HIFU treatment was well tolerated and showed efficacy (mean volume reduction of 72.5% +/-16.7 at 12 months follow-up.

02

Conditions studied

  • Breast Fibroadenoma

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03

In context

Fibroadenoma

27 studies on the registry are indexed under Fibroadenoma; 6 are open to participants now.

This study's enrollment of 15 is below the median of 50 across 20 interventional studies indexed under Fibroadenoma.

Browse Fibroadenoma studies →

Lead sponsor

Theraclion is the lead sponsor of 18 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female patients 18 years or older with one diagnosed breast 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 (Breast Imaging, Reporting and Data System) score of this mammogram must be less than 3.
    • histologic confirmation after core needle by two independent readers (biopsy must be performed at least two weeks before therapy unless a microbiopsy has been already done less than 3 months before inclusion visit and histopathology slices are available).

  • The requirements for the distance from the skin and the following regions of the fibroadenoma are:

    • ≤ 23 mm from the posterior border of the fibroadenoma
    • ≥ 5 mm from the anterior border of the fibroadenoma
    • ≥ 11mm from the focal point of the HIFU treatment. These criteria shall be evaluated immediately prior to treatment once breast is immobilized and potentially compressed
  • The rib cage should not be in the prefocal ultrasound path or behind the target fibroadenoma (minimum distance behind the focal point= 10 mm). This criterion shall only be reached in treatment conditions, once breast is immobilized and potentially compressed.
  • Patient's fibroadenoma is 1 cm or greater at its largest dimension
  • Fibroadenoma is palpable
  • Patient has signed a written .

Exclusion criteria

Exclusion Criteria:

  • Patient who is pregnant or lactating.
  • Patient with a BI-RADS score > 2 at the mammogram, or presence of microcalcifications within the lesion.
  • Patient with history of breast cancer or history
  • Patient with history of laser or radiation therapy to the target breast
  • Patient with breast implants in the target breast
  • Patient with a breast cyst
  • Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit
  • Patient participating in other trials using drugs or devices.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Echopulse

    Echopulse HIFU

    Device: Echopulse

Interventions

  • DeviceEchopulse

    HIFU Under ultrasound guidance

    Also known as: Echopulse HIFU

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events

    Time frame: 1 day post treatment

  2. Number of participants with adverse events

    Time frame: 3 days post treatment

  3. Number of participants with adverse events

    Time frame: 7 days post treatment

  4. Change from Baseline volume of the fibroadenoma at 6 months

    Time frame: 6 months post treament

  5. Change from Baseline Patient pain intensity score (100mm visual analog scale) at 1 day

    Time frame: 1 day post treatment

  6. Change from Baseline Patient pain intensity score (100mm visual analog scale) at 3 days

    Time frame: 3 days post treatment

  7. Change from Baseline Patient pain intensity score (100mm visual analog scale) at 7 days

    Time frame: 7 days post treatment

  8. Patient satisfaction questionnaire

    Time frame: 6 months post treatment

Secondary outcomes

  1. Number of participants with absence of palpable lesion

    Time frame: 3 months post treatment

  2. Number of participants with absence of palpable lesion

    Time frame: 6 months post treatment

  3. Patient Cosmetic evaluation as measured by questionnaire

    Time frame: 6 months post treatment

  4. Investigator rated evaluation of the device

    Time frame: Post treatment Day 0

  5. Change from Baseline gland vascularization at 3 months

    Time frame: 3 months post treatment

  6. Change from Baseline gland vascularization at 6 months

    Time frame: 6 months post treatment

07

Study locations

1 site
  • University Hospital of Endocrinology USBALE
    Sofia, 1431, Bulgaria
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2015, a primary completion of Dec 2018 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 24, 2015
First posted
Jul 2, 2015
Start
Jun 2015
Primary completionActual
Dec 2018
CompletionActual
Dec 2018
Last update
Oct 19, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02488655
Lead sponsor
Theraclion
Responsible party
Sponsor
First posted
Jul 2, 2015
Start date
Jun 2015
Primary completion
Dec 2018
Completion
Dec 2018
Last update
Oct 19, 2021

Study contacts

Roussanka Kovatcheva, Prof.
principal investigator · roussanka_kov@yahoo.com

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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