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

Theraclion

Status: Completed

Conditions: Breast Fibroadenoma

Treatments: Device: HIFU treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02139683

HIFU-F

Details and patient eligibility

About

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

Full description

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

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

HIFU treatment

Experimental group

Description:

HIFU treatment in patient diagnosed with fibroadenoma

Treatment:

Device: HIFU treatment