Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Breast Cancer

Treatments: Device: EnVisio™ Navigation System; Device: EnVisio SmartClip

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04604561

MCC-20335

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

50 participants in 3 patient groups

Participants receiving SmartClip

Description:

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.

Treatment:

Device: EnVisio SmartClip

Device: EnVisio™ Navigation System

Radiologist Placing SmartClip

Description:

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.

Treatment:

Device: EnVisio SmartClip

Device: EnVisio™ Navigation System

Surgeon

Description:

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

Treatment:

Device: EnVisio SmartClip

Device: EnVisio™ Navigation System