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Ultrasound Therapy

ECHOPULSE for Breast Fibroadenoma (HIFU-003 Trial)

N/A

Recruiting

Research Sponsored by Theraclion

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6 and months 12

Awards & highlights

HIFU-003 Trial Summary

This trial found that HIFU is a safe and effective treatment for breast fibroadenoma with no significant side effects.

Who is the study for?

This trial is for women over 18 with breast fibroadenoma, a non-cancerous breast lump. Participants must have a confirmed diagnosis, be candidates for surgery, and not be pregnant or nursing. The fibroadenoma should be visible on ultrasound, at least 1 cm in size but no larger than 10 cc in volume, and not contain calcifications or implants.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of High-Intensity Focused Ultrasound (HIFU), using ECHOPULSE to treat breast fibroadenomas. It aims to see if this non-invasive treatment can reduce pain and anxiety associated with these lumps without traditional surgery.See study design

What are the potential side effects?

Potential side effects may include discomfort during the procedure, skin redness or bruising where the HIFU was applied, temporary numbness or tingling in the treated area due to nerve irritation.

HIFU-003 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6 and months 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6 and months 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 and months 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anxiety level assessment

Pain level assessment

Volume assessment

Secondary outcome measures

Freedom from additional procedures for fibroadenoma of the breast

Palpability of the breast fibroadenoma

Patient satisfaction

+2 more

HIFU-003 Trial Design

1Treatment groups

Experimental Treatment

Group I: ECHOPULSEExperimental Treatment1 Intervention

ECHOPULSE HIFU

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ECHOPULSE

2017

N/A

~50

Do I qualify?Apply below to find out

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Who is running the clinical trial?

TheraclionLead Sponsor

20 Previous Clinical Trials

623 Total Patients Enrolled

7 Trials studying Breast Fibroadenoma

165 Patients Enrolled for Breast Fibroadenoma

Michel NUTA, MDStudy DirectorTheraclion

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining vacancies for participants in this research project?

"Affirmative. The information published on clinicaltrials.gov reveals that this research is currently in the process of recruiting participants. Originally posted on January 1st 2017, with a most recent update made October 18th 2022, 100 volunteers are required from 4 distinct medical centres for successful completion of the trial."

Answered by AI

How many participants are being accepted for this investigation?

"Affirmative. According to clinicaltrials.gov, this research project is in need of patient volunteers and was initially shared on January 1st 2017 with the most recent update taking place October 18th 2022. Up to 100 participants may be accepted at 4 distinct medical facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Breast Fibroadenoma Targeted Tissue With HIFU

2017. "Treatment of Breast Fibroadenoma Targeted Tissue With HIFU". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03044054.