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Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses | Clinical Trials | Clareo Health

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Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses

Physician Initiated Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses

NCT04604561•H. Lee Moffitt Cancer Center and Research Institute

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must have at least one and up to 3 sonographically or mammographically identifiable in-breast or axillary targets and consent to undergo a surgical resection using the SmartClip localization system at the McKinley operative suites at Moffitt Cancer Center. Multiple sites for localization may be used, up to a maximum of 3 SmartClips per patient. Mammographically or sonographically visible biopsy clips may be used as a localizing target.
•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
•Patients requiring use of more than 3 SmartClips to localize targets

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States

Key Dates

Start Date

October 27, 2020

Primary Completion Date

July 26, 2023

Completion Date

July 26, 2023

Last Updated

January 8, 2026

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

EnVisio SmartClip

DEVICE

EnVisio™ Navigation System

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses

Inclusion Criteria

Exclusion Criteria

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