Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses

March 31, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited to this study from the Moffitt Cancer Center Comprehensive Breast Clinic. Patients are seen in this clinic by breast surgeons from the Comprehensive Breast Program at Moffitt Cancer Center.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants receiving SmartClip
Participants will undergo a preoperative physical exam and at least one preoperative ultrasound demonstrating the mass for resection. The SmartClip will be placed under ultrasound guidance. Post-placement mammogram will be obtained after placement of the clip. The SmartClip can be placed up to 30 days prior to the planned surgical resection. At the time of definitive surgery, the Envisio system will be used to identify the clip and the targeted lesion for resection. Intraoperatively, a specimen radiograph will be performed to confirm the presence of the SmartClip and the targeted lesion in the surgical specimen. The breast surgical specimen will be sent for gross examination, including measurements of the tumor in 3 axes. Immediately post-procedure, the performing surgeon will fill out a questionnaire to determine the ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery.
Device: EnVisio SmartClip
The Envisio SmartClip is an FDA-cleared (approved) device for localization of in-breast lesions. While using The EnVisio™ Navigation System, the system will detect the presence of the SmartClip™ Soft Tissue Marker(s) and provide real-time three-dimensional navigation during the surgery.
Device: EnVisio™ Navigation System
The EnVisio™ Navigation System acquires and analyzes electromagnetic signatures that display the relative distance, depth, and direction from the tip of the electrosurgical tool to the implanted SmartClipTM(s) within the surgeon's field of view during the procedure.
Radiologist Placing SmartClip
Radiologist will place SmartClip under ultrasound guidance. A Post-placement mammogram will be obtained after placement of the SmartClip. Immediately post-procedure, the performing radiologist will fill out a questionnaire.
Device: EnVisio SmartClip
The Envisio SmartClip is an FDA-cleared (approved) device for localization of in-breast lesions. While using The EnVisio™ Navigation System, the system will detect the presence of the SmartClip™ Soft Tissue Marker(s) and provide real-time three-dimensional navigation during the surgery.
Device: EnVisio™ Navigation System
The EnVisio™ Navigation System acquires and analyzes electromagnetic signatures that display the relative distance, depth, and direction from the tip of the electrosurgical tool to the implanted SmartClipTM(s) within the surgeon's field of view during the procedure.
Surgeon
The surgeon will use the EnVisio™ Navigation System to identify the SmartClip and the targeted lesion for resection. Immediately post-procedure, the performing surgeon will fill out a questionnaire
Device: EnVisio SmartClip
The Envisio SmartClip is an FDA-cleared (approved) device for localization of in-breast lesions. While using The EnVisio™ Navigation System, the system will detect the presence of the SmartClip™ Soft Tissue Marker(s) and provide real-time three-dimensional navigation during the surgery.
Device: EnVisio™ Navigation System
The EnVisio™ Navigation System acquires and analyzes electromagnetic signatures that display the relative distance, depth, and direction from the tip of the electrosurgical tool to the implanted SmartClipTM(s) within the surgeon's field of view during the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery - Radiologist Cohort
Time Frame: 1 year
Questions 1,2,5,6,7 & 8 from the Radiologist survey will evaluate the EnVisio system for reproducible in-breast tumor localization by the performing physicians.
1 year
Ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery - Surgeon Cohort
Time Frame: 1 year
Questions 4, 5, 6, 8, 9, 10, & 11 from the Surgeon survey will evaluate the EnVisio system for reproducible in-breast tumor localization by the performing physicians.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Placement of the SmartClip on preoperative imaging to clip location on specimen radiography
Time Frame: 1 year
Radiologists will take radiologist questionnaire evaluating their experience using the SmartClip
1 year
Placement and visibility of the clip by breast radiologists
Time Frame: 1 year
Radiologists will take radiologist questionnaire evaluating their experience using the SmartClip
1 year
Intraoperative use of the device system by surgeons
Time Frame: 1 year
Surgeons will take surgeon questionnaire evaluating their experience using the SmartClip and EnVisio™ Navigation System
1 year
Surgical outcomes with use of the SmartClip
Time Frame: 1 year
Surgeons will take surgeon questionnaire evaluating their experience using the SmartClip and EnVisio™ Navigation System
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Elucent Medical

Investigators

  • Principal Investigator: M. Catherine Lee, MD, Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2020

Primary Completion (Actual)

July 26, 2023

Study Completion (Actual)

July 26, 2023

Study Registration Dates

First Submitted

October 9, 2020

First Submitted That Met QC Criteria

October 21, 2020

First Posted (Actual)

October 27, 2020

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-20335

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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