Breast Cancer Clinical Trial

Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses

Summary

This is a pilot study to estimate the success of the SmartClip device for accurate placement and reproducibility of intraoperative identification of in-breast lesions and for excision utilizing surgical navigation indicators.

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Eligibility Criteria

Inclusion Criteria:

Participants must have a sonographically or mammographically identifiable in-breast lesion measuring at least 5.0mm on ultrasound imaging and consent to undergo a surgical resection using the SmartClip localization system at the McKinley operative suites at Moffitt Cancer Center
Participants must be age > or = 18 years.

Exclusion Criteria:

Participants with sonographically or mammographically occult target lesions
Participants with greater than 35cm chest to bust depth
Participants undergoing mastectomy for resection of the targeted lesion
Inability to undergo surgery at the McKinley OR suites due to institutional anesthesia guidelines

Study is for people with:

Breast Cancer

Estimated Enrollment:

50

Study ID:

NCT04604561

Recruitment Status:

Suspended

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

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There is 1 Location for this study

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Moffitt Cancer Center
Tampa Florida, 33612, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

50

Study ID:

NCT04604561

Recruitment Status:

Suspended

Sponsor:


H. Lee Moffitt Cancer Center and Research Institute

How clear is this clinincal trial information?

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