Feasibility Study Assessing the Treatment of Fibroadenoma... | NCT02139683

Studies
Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU

NCT02139683

Sponsor

Theraclion

Status

Completed

Last Update Posted

May 30, 2018Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Breast Fibroadenoma

Interventions

HIFU treatment

Countries

United Kingdom

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

May 2018

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

Jan 2014Actual

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Feb 5, 2014

First Submission Date that Met QC Criteria

May 13, 2014

First Posted Date

May 15, 2014Estimated

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

May 25, 2018

Last Update Posted Date

May 30, 2018Actual

Name	Class
King's College London	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to assess the treatment of fibroadenomata with a circumferential sonification treatment with HIFU..

Detailed Description

Primary endpoint: fibroadenomata size reduction post-treatment on ultrasound imaging.

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HIFU treatment	Experimental	HIFU treatment in patient diagnosed with fibroadenoma	Device: HIFU treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HIFU treatment	Device	HIFU treatment in patients with fibroadenoma	HIFU treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in size of fibroadenomata as recorded on ultrasound imaging		Month 1, Month 3, Month 12

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events		Month 1, Month 3, Month 12
Patient recorded outcomes measures	Patient questionnaires and VAS scales	Month 1, Month 3, Month 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients >18 years of age
Fibroadenomata diagnosed according to local hospital protocol; ultrasound alone on patients <25 and ultrasound plus core-biopsy in patients >25 (Graded B2 or less)
Visible on ultrasound (Graded U2/U3)
Definitive diagnosis of fibroadenomata confirmed by the Breast multi-disciplinary team meeting (MDT).

Exclusion Criteria:

Lesion with atypia or suspicion of phyllodes (Graded B3 or greater)
Pregnant or lactating women
History of laser or radiation therapy to the targeted breast

Accepts Healthy Volunteers

Sex

All

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
Michael Douek, MD	King's College London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kings College London, Guy's & St Thomas' Hospitals, Department of Research Oncology		London		SE1 9RT	United Kingdom

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