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COMPLETED
NCT02794558
NA

Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas

Sponsor: InSightec

View on ClinicalTrials.gov

Summary

Non-randomized, Single Arm Clinical study to Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas

Official title: A Clinical Study To Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

91

Start Date

2005-05-24

Completion Date

2019-03-01

Last Updated

2026-09-08

Healthy Volunteers

No

Conditions

Interventions

DEVICE

ExAblate MRgFUS

MR images of the breast will be obtained for lesion localization purposes. The breast surgeon or the radiologist will make a treatment plan or map. Sonication at therapeutic power level will be performed on multiple overlapping points successively until sonication of the target volume has been completed. Follow-up evaluation will be made within 14 to 21 days after the MRgFUS treatment.

Locations (1)

Breastopia Miyazaki Hospital

Miyazaki, Miyazaki, Japan