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:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-25 @ 4:43 AM
NCT ID:
NCT02432118
Eligibility Criteria:
Inclusion Criteria:
* Have had stereotactic or ultrasound-guided biopsy with marker placement
* Have a lesion or biopsy marker that is visible under ultrasound
* Have a surgical target =\< 6 cm from the skin when lying supine
* Have a discreet surgical target
* Have a lesion in which the center/focal area is defined
* Have the ability to understand and the willingness to sign a written informed consent document
* Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status will not be used as an inclusion criterion
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Require more than one localization needle for localization of the surgical target (bracket localization)
* Have undergone previous open surgical biopsy, lumpectomy, or mastectomy in the operative breast
* Have a prosthesis/implant in the operative breast
* Have a cardiac pacemaker or defibrillator device
* Be contraindicated for surgery
* Be pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02432118
Study Brief:
Protocol Section:
NCT02432118