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

NCT02011919 | Completed

• 1 other identifier: HIFU / TU / FA
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• FA volume changes from baseline

  Every year during 5 years

Secondary Outcomes (9)

• Palpability

  Every year during 5 years

• Pain assessment

  Every year during 5 years

• Cosmetic result

  Every year during 5 years

• Gland vascularisation

  Every year during 5 years

• Histological outcome

  Every year during 5 years

Study Arms (1)

Echopulse

OTHER

Echopulse HIFU

Device: Echopulse

Interventions

Echopulse DEVICE

HIFU Under ultrasound guidance

Echopulse

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient who is pregnant or breast-feeding.
• 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.

Sponsors & Collaborators

• Theraclion: lead

Study Sites (1)

Tubingen University Hospital

Tübingen, Germany

Location

Related Publications (1)

• 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.

  PMID: 30204024 DERIVED

MeSH Terms

Conditions

Fibroadenoma

Condition Hierarchy (Ancestors)

Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 13, 2013
• Study Start: December 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: May 30, 2018

Record last verified: 2018-05

Locations

DE (1)