Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-02-25 @ 4:38 PM
Study NCT ID:
NCT02794558
Status:
COMPLETED
Last Update Posted:
2019-07-01
First Post:
2016-06-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas
Sponsor:
InSightec
Organization:
Study Overview
Official Title:
A Clinical Study To Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Study specific aim is to Coagulate the tissue volume of a proven breast cancer with MRgFUS and Collect post treatment follow-up clinical and radiological data for a period of 5 years following MRgFUS for breast cancer.
Safety of the treatment will be evaluated by recording and assessing the incidence and severity of device- related complications from the first visit through the 5 years follow-up period.
Secondary objective of this study is to evaluate post treatment local recurrence in the same quadrant or less then 4cm from the periphery of the treated lesion, during a 5 year period following the MRgFUS treatment.
Women with breast cancer in whom breast MR imaging identifies a single focal breast lesion up to 1.5 cm in diameter will be eligible for the study.
Safety of the treatment will be evaluated by recording and assessing the incidence and severity of device- related complications from the first visit through the 5 years follow-up period.
Secondary objective of this study is to evaluate post treatment local recurrence in the same quadrant or less then 4cm from the periphery of the treated lesion, during a 5 year period following the MRgFUS treatment.
Women with breast cancer in whom breast MR imaging identifies a single focal breast lesion up to 1.5 cm in diameter will be eligible for the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: