CompletedNot Applicable

Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses

United States50 participantsStarted 2020-10-27

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 year

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

Timeframe: 1 year

Trial details

NCT IDNCT04604561

SponsorH. Lee Moffitt Cancer Center and Research Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-07-26

View on ClinicalTrials.gov More Breast Cancer trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.