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

NCT03742401 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-03-16

No results posted yet for this study

Summary

This is a multi-center, crossover study with cluster randomization and a planned accrual of 300 patients with diagnosed breast fibroadenoma (One fibroadenoma treated per patient). This is a trial based prospective cost consequence study. Costs will be estimated from the viewpoint of the healthcare system and from the patient's perspective

Conditions

  • Breast Fibroadenoma

Interventions

PROCEDURE

Surgery

Traditional open excisional surgery

DEVICE

HIFU (Echopulse)

High intensity focused ultrasound (HIFU) non invasive intervention

Sponsors & Collaborators

  • Theraclion

    lead INDUSTRY

Principal Investigators

  • Richard Villet, PI · Groupe Hospitaliler Diaconesses

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-11
Primary Completion
2019-04-30
Completion
2019-04-30

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 NCT03742401 on ClinicalTrials.gov