NCT01331954

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2011

Completed
13.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

13.5 years

First QC Date

April 7, 2011

Last Update Submit

April 10, 2024

Conditions

Breast Fibroadenoma

Outcome Measures

Primary Outcomes (1)

  • Reduction of breast fibroadenoma volume at ultrasonography

    12 months

Study Arms (1)

HIFU

EXPERIMENTAL
Device: Ultrasonic ablation device

Interventions

Ultrasonic ablation deviceDEVICE

One or two HIFU procedures

Also known as: TH-One
HIFU

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"

Sofia, 1431, Bulgaria

Location

Related Publications (1)

  • 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.

    PMID: 28331611DERIVED

MeSH Terms

Conditions

Fibroadenoma

Condition Hierarchy (Ancestors)

Neoplasms, FibroepithelialNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and Epithelial

Study Officials

  • Roussanka Kovatcheva, M

    University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2011

First Posted

April 8, 2011

Study Start

March 1, 2011

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

April 11, 2024

Record last verified: 2024-04

Locations

BU(1)