Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

NCT ID: NCT02011919

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2017-01-31

Brief 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

Conditions

Breast Fibroadenoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Echopulse

Echopulse HIFU

Group Type: OTHER

Echopulse

Intervention Type: DEVICE

HIFU Under ultrasound guidance

Interventions

Echopulse

HIFU Under ultrasound guidance

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Theraclion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tubingen University Hospital

Tübingen, , Germany

Countries

Germany

References

Hahn M, Fugunt R, Schoenfisch B, Oberlechner E, Gruber IV, Hoopmann U, Roehm C, Helms G, Taran FA, Hartkopf AD, Warzecha H, Wiesinger B, Brucker SY, Boeer B. High intensity focused ultrasound (HIFU) for the treatment of symptomatic breast fibroadenoma. Int J Hyperthermia. 2018;35(1):463-470. doi: 10.1080/02656736.2018.1508757. Epub 2018 Sep 11.

Reference Type: DERIVED

PMID: 30204024 (View on PubMed)

Other Identifiers

HIFU / TU / FA

Identifier Type: -

Identifier Source: org_study_id