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

NCT ID: NCT02139683

Last Updated: 2018-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-01-31

Brief Summary

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

Detailed Description

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

Conditions

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Breast Fibroadenoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HIFU treatment

HIFU treatment in patient diagnosed with fibroadenoma

Group Type EXPERIMENTAL

HIFU treatment

Intervention Type DEVICE

HIFU treatment in patients with fibroadenoma

Interventions

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HIFU treatment

HIFU treatment in patients with fibroadenoma

Intervention Type DEVICE

Other Intervention Names

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Echopulse

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role collaborator

Theraclion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Douek, MD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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Kings College London, Guy's & St Thomas' Hospitals, Department of Research Oncology

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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HIFU-F

Identifier Type: -

Identifier Source: org_study_id

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