Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04604561
• Other study ID #: MCC-20335
• Status: Completed
• Start date: October 27, 2020
• Est. completion date: July 24, 2023

Study information

• Verified date: March 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 24, 2023
• Est. primary completion date: July 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Elucent Medical

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Moffitt Cancer Center Clinical Trial Search