High Intensity Focused Ultrasound (HIFU) to Treat Breast... | NCT01422629

Studies
High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma

NCT01422629

Sponsor

Theraclion

Status

Completed

Last Update Posted

Apr 9, 2014Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Breast Fibroadenoma

Interventions

Ultrasonic ablation device

Countries

France

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 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Aug 18, 2011

First Submission Date that Met QC Criteria

Aug 23, 2011

First Posted Date

Aug 24, 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 8, 2014

Last Update Posted Date

Apr 9, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a multicentre, open, uncontrolled trial for the observation of histological changes in breast fibroadenoma following high intensity focused ultrasound (HIFU).

This study will be conducted in France in 20 patients with breast fibroadenoma with indication for a surgical resection. The patient will receive an HIFU treatment and 6 months after treatment, the need of the surgery is evaluated.

Detailed Description

Not provided

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High Intensity Focused Ultrasound (HIFU)	Experimental		Device: Ultrasonic ablation device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasonic ablation device	Device	High Intensity focused ultrasound treatment	High Intensity Focused Ultrasound (HIFU)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HIFU induced tissue necrosis assessed by histology of excised gland or reduction volume of fibroadenoma		6 months after HIFU treatment

Secondary Outcomes

Measure	Description	Time Frame
Volume reduction of the fibroadenoma	reduction in volume at 2, 4, 6 and 12 months after HIFU session or total regression of the fibroadenoma evaluated with ultrasound just before surgery	12 months after HIFU treatment
- Pain score during the HIFU treatment evaluated by the Visual Analog Scale.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of breast fibroadenoma based on:Clinical examination, Ultrasound image and mammogram for women older than 35 years, and histology
Fibroadenoma size superior at 1 cm at its largest dimension (measured by Ultrasound)

Exclusion Criteria:

Patient pregnant or lactating
Microcalcifications within the lesion at the mammogram.
History of breast cancer or history of laser or radiation therapy to the target breast
Breast implant in the target breast.
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
Loïc BOULANGER, MD	Hôpital Jeanne de Flandre, CHU de Lille - FRANCE	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Jeanne de Flandre, CHU de Lille 2 Avenue Oscar Lambret		Lille		59000	France
Hôpital Américain de Paris

Condition Browse Module

MeSH Terms

ID	Term
D018226	Fibroadenoma

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided