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Completed

NCT Number: NCT04604561

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. Placement and visibility of the clip by breast radiologists

    Time frame: 1 year

    Radiologists will take radiologist questionnaire evaluating their experience using the SmartClip

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Elucent Medical

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2020
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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