Treatment of Breast Fibroadenoma With High Intensity Focu... | NCT01331954

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

NCT01331954

Sponsor

Theraclion

Status

Unknown status

Last Update Posted

Apr 11, 2024Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Breast Fibroadenoma

Interventions

Ultrasonic ablation device

Countries

Bulgaria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011Actual

Primary Completion Date

Sep 2024Estimated

Completion Date

Sep 2024Estimated

First Submitted Date

Apr 7, 2011

First Submission Date that Met QC Criteria

Apr 7, 2011

First Posted Date

Apr 8, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2024

Last Update Posted Date

Apr 11, 2024Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HIFU	Experimental		Device: Ultrasonic ablation device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasonic ablation device	Device	One or two HIFU procedures	HIFU

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of breast fibroadenoma volume at ultrasonography		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roussanka Kovatcheva, M	University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"		Sofia		1431	Bulgaria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28331611	Derived	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.

ID	Term
D018225	Neoplasms, Fibroepithelial
D018218	Neoplasms, Fibrous Tissue
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue