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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

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

Who can participate

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

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
04

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

05

What researchers measure

Primary outcomes

  1. Reduction of breast fibroadenoma volume at ultrasonography

    Time frame: 12 months

06

Study locations

1 site
  • University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"
    Sofia, 1431, Bulgaria
07

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 ↗
08

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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