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Search / Trial NCT04604561

Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses

Launched by H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE · Oct 21, 2020

Trial Information

Current as of May 09, 2025

Completed

Keywords

Smart Clip En Visio™ Navigation System

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • 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

About H. Lee Moffitt Cancer Center And Research Institute

H. Lee Moffitt Cancer Center and Research Institute is a leading institution dedicated to cancer research, treatment, and education, recognized for its commitment to advancing cancer care through innovative clinical trials and groundbreaking research. As a National Cancer Institute-designated Comprehensive Cancer Center, Moffitt integrates cutting-edge science with patient-centered care, offering a multidisciplinary approach to cancer treatment. The center is at the forefront of developing novel therapies and improving outcomes for patients, emphasizing collaboration between researchers and clinicians to translate scientific discoveries into effective treatments. Through its extensive clinical trial programs, Moffitt aims to enhance the understanding of cancer biology and provide patients with access to the latest therapies and interventions.

Locations

Tampa, Florida, United States

Patients applied

0 patients applied

Trial Officials

M. Catherine Lee, MD

Principal Investigator

Moffitt Cancer Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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