Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses

NCT04604561 | Completed FDA Device

• 1 other identifier: MCC-20335
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

SmartClip; EnVisio™ Navigation System

Outcome Measures

Primary Outcomes (2)

• Ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery - Radiologist Cohort

  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

  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 Outcomes (4)

• Placement of the SmartClip on preoperative imaging to clip location on specimen radiography

  1 year

• Placement and visibility of the clip by breast radiologists

  1 year

• Intraoperative use of the device system by surgeons

  1 year

• Surgical outcomes with use of the SmartClip

  1 year

Study Arms (3)

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; Device: EnVisio™ Navigation System

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; Device: EnVisio™ Navigation System

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; Device: EnVisio™ Navigation System

Interventions

EnVisio SmartClip DEVICE

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.

Participants receiving SmartClip; Radiologist Placing SmartClip; Surgeon

EnVisio™ Navigation System DEVICE

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.

Participants receiving SmartClip; Radiologist Placing SmartClip; Surgeon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Elucent Medical: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trial Search

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• M. Catherine Lee, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 27, 2020
• Study Start: October 27, 2020
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (1)