FindMyKOL
Clinical trialNCT00147108TerminatedPhase 3Interventional

MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas

SponsorInSightecEnrollment102Breast Fibroadenoma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The primary objective of this pivotal study is to evaluate the safety and efficacy of FUS treatment of breast fibroadenomas. Our hypothesis is that FUS lesion ablation of a fibroadenoma will have the following results: a. lead to a decrease in lesion cross-sectional area of \> 50% on palpation, and \>65% in lesion volume as measured by MRI (both calculations assume an elliptical shape of the lesion in all 3 dimensions). b. this decrease in size, along with the softening of the treated volume will result in satisfactory clinical results in greater than 50 % of the patients.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Japan
  • Breastopia Namba Hospital

    Miyazaki-ken, Japan

United States
  • University Mri

    Boca Raton, Florida, United States

  • Brigham & Women'S Hospital

    Boston, Massachusetts, United States

  • Virtua

    Voorhees Township, New Jersey, United States

  • Cornell Vascular

    New York, New York, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jan 2003
Primary completion
31 Aug 2005
Completion
31 Oct 2005
Last update posted
17 Sept 2012
Registered enrollment
102
Registry id
NCT00147108
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.