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High Intensity Focused Ultrasound (HIFU) to Treat Breast Fibroadenoma

NCT01422629 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-04-09

No results posted yet for this study

Summary

This study is a multicentre, open, uncontrolled trial for the observation of histological changes in breast fibroadenoma following high intensity focused ultrasound (HIFU).

This study will be conducted in France in 20 patients with breast fibroadenoma with indication for a surgical resection. The patient will receive an HIFU treatment and 6 months after treatment, the need of the surgery is evaluated.

Conditions

  • Breast Fibroadenoma

Interventions

DEVICE

Ultrasonic ablation device

High Intensity focused ultrasound treatment

Sponsors & Collaborators

  • Theraclion

    lead INDUSTRY

Principal Investigators

  • Loïc BOULANGER, MD · Hôpital Jeanne de Flandre, CHU de Lille - FRANCE

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01422629 on ClinicalTrials.gov