Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2025-12-24 @ 12:39 PM
NCT ID:
NCT04604561
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04604561
Study Brief:
Protocol Section:
NCT04604561