Overview

This trial is active, not recruiting.

Condition breast fibroadenoma
Treatment echopulse
Phase phase 2/phase 3
Sponsor Theraclion
Start date December 2013
End date December 2018
Trial size 27 participants
Trial identifier NCT02011919, HIFU / TU / FA

Summary

This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device

Objectives Primary objective: To evaluate the efficacy of HIFU in the treatment of the breast fibroadenoma using the TH-One device Secondary objective: To evaluate the tolerability of the HIFU using the TH-One device

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Echopulse HIFU
echopulse
HIFU Under ultrasound guidance

Primary Outcomes

Measure
FA volume changes from baseline
time frame: Every year during 5 years

Secondary Outcomes

Measure
Palpability
time frame: Every year during 5 years
Pain assessment
time frame: Every year during 5 years
Cosmetic result
time frame: Every year during 5 years
Gland vascularisation
time frame: Every year during 5 years
Histological outcome
time frame: Every year during 5 years
Energy settings
time frame: Every year during 5 years
Breast immobilization
time frame: Every year during 5 years
Duration of the treatment session
time frame: Every year during 5 years
Ease of implementation of treatment
time frame: Every year during 5 years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Female patients 18 years or older with at least one diagnosed breast fibroadenoma. - Diagnosis of fibroadenoma must be based on: - clinical examination, - women ≤ 40 years of age: ultrasound image alone; women > 40 years of age: ultrasound image and mammogram, - histological confirmation of fibroadenoma of the breast. - Patient's fibroadenoma size as determined by ultrasound imaging: the longest diameter is limited to 25 mm. - Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to HIFU treatment. - Patient must be able to understand the nature and the extent of the study and the procédures required and be willing and able to complete the screening and study procedures. - Patient must give written informed consent (personally signed and dated) before completing any study-related procedure. Exclusion Criteria: - Patient who is pregnant or breast-feeding. - Patient with history of ipsilateral breast cancer within 5 years prior to study inclusion or radio therapy to the target breast within 5 years prior to study inclusion. - Patient with implant on the treated breast. - Patient with target fibroadenoma pre-treated by cryoablation or interstitial laser therapy within 12 month before recruiting for HIFU. - Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the inclusion visit. - Patient participating in other studies using drugs or medical devices within 3 months prior to study inclusion or during study participation including the follow-up period.

Additional Information

Official title Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Theraclion.