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Active, not recruitingNCT01331954Updated Apr 11, 2024

Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

An interventional study of Ultrasonic ablation device in Breast Fibroadenoma, sponsored by Theraclion. Active, not recruiting at 1 site in Bulgaria. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-11.

Sponsored by Theraclion · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 2 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast fibroadenoma.

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 planned enrollment of 20 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

  • One breast fibroadenoma with diagnosis based on:

    • Clinical examination
    • Ultrasound image
    • For women older than 35 years: mammogram with BI-RADS score \< 3
    • Histologic confirmation by two independent readers
  • Fibroadenoma size between 1 cm and 3 cm at its largest dimension (measured by ultrasound)

Exclusion criteria

Exclusion Criteria:

  • Patient pregnant or lactating
  • Bi-RADS score > 2 at the mammogram, or microcalcifications within the lesion.
  • History of breast cancer or history of laser or radiation therapy to the target breast
  • Breast implants
  • Breast cyst
  • Fibroadenoma not clearly visible on the ultrasound images (in B mode)
  • Patient participating in other trials using drugs or devices
05

Study design

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

Study arms

  • Experimental
    HIFU

    Device: Ultrasonic ablation device

Interventions

  • DeviceUltrasonic ablation device

    One or two HIFU procedures

    Also known as: TH-One

06

What researchers measure

Primary outcomes

  1. Reduction of breast fibroadenoma volume at ultrasonography

    Time frame: 12 months

07

Study locations

1 site
  • University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"
    Sofia, 1431, Bulgaria
08

References and documents

Publications

  • Kovatcheva R, Zaletel K, Vlahov J, Stoinov J. Long-term efficacy of ultrasound-guided high-intensity focused ultrasound treatment of breast fibroadenoma. J Ther Ultrasound. 2017 Mar 16;5:1. doi: 10.1186/s40349-017-0083-1. eCollection 2017. PubMed 28331611 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2011 (actual). Primary completion is estimated for Sep 2024, 162 months after the start.

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

Registered
Apr 7, 2011
First posted
Apr 8, 2011
StartActual
Mar 2011
Primary completionEst.
Sep 2024
CompletionEst.
Sep 2024
Last update
Apr 11, 2024
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 Apr 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01331954
Lead sponsor
Theraclion
Responsible party
Sponsor
First posted
Apr 8, 2011
Start date
Mar 2011
Primary completion
Sep 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Apr 11, 2024

Study contacts

Roussanka Kovatcheva, M
principal investigator · University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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