| Primary | Patients With Successful Placement of the Radiofrequency Tag Under Radiographic Guidance Confirmed by Mammography | Patients with successful radiofrequency tag placement | | Posted | | Count of Participants | | Participants | | at time of device placement, confirmed by mammography | | | | ID | Title | Description |
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| OG000 | Diagnostic (Radiofrequency-guided Localization) | Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag |
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| Primary | Patients With Successful Retrieval of the Radiofrequency Tag Confirmed by Specimen Radiography | Patients with successful radiofrequency tag retrieval. | | Posted | | Count of Participants | | Participants | | at time of surgery, within 30 days of tag implant | | | | ID | Title | Description |
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| OG000 | Diagnostic (Radiofrequency-guided Localization) | Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag |
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| Secondary | Days Prior to Surgery of Insertion of Marker | Mean number of days before surgery that radiofrequency tag was placed. | | Posted | | Mean | Standard Deviation | days | | Up to 30 days prior to surgery | | | | ID | Title | Description |
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| OG000 | Diagnostic (Radiofrequency-guided Localization) | Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag |
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| Secondary | Patient Experience With Image-guided Placement of Tag as Rated by a Patient Questionnaire | The patient experience with image-guided placement of the radio frequency Identification (RFID) tag.This assessments was captured using Likert-type questionnaires. Individual question responses for the patient and physician questionnaires ranged from 1 to 5 with the score of 5 representing the maximum positive or favorable response to each question. The following choices were included in each questionnaire:
- Strongly disagree
- Disagree
- Neutral
- Agree
- Strongly Agree
Responses of the individual scales were added to create a total score, which would include a possible total range of 5 to a maximum of 25 points. 25 is the maximum positive or favorable response. | | Posted | | Mean | Standard Deviation | units on a scale | | within 24 hours of device placement | | | | ID | Title | Description |
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| OG000 | Diagnostic (Radiofrequency-guided Localization) | Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag |
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| Secondary | Patients With Cancer Requiring Re-excision | Patients requiring re-excision. | | Posted | | Count of Participants | | Participants | | up to 4 weeks post initial surgery | | | | ID | Title | Description |
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| OG000 | Diagnostic (Radiofrequency-guided Localization) | Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag |
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| Secondary | Patients With Documented Migration of Marker | Movement of radiofrequency tag from point of placement | | Posted | | Count of Participants | | Participants | | at time of surgery, within 30 days of tag implant | | | | ID | Title | Description |
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| OG000 | Diagnostic (Radiofrequency-guided Localization) | Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag |
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| Secondary | Patients With Positive Margins on Initial Lumpectomy Using Radiofrequency Identification Technology | Patients with margins of excisable tissue remaining. | | Posted | | Count of Participants | | Participants | | at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery | | | | ID | Title | Description |
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| OG000 | Diagnostic (Radiofrequency-guided Localization) | Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag |
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| Secondary | Radiologist's Experience Placing Radiofrequency Tag Compared to Wire Localization as Measured by a Radiologist's Questionnaire | The radiologist's experience with image-guided placement of the RFID tag.This assessments was captured using Likert-type questionnaires. Individual question responses for the patient and physician questionnaires ranged from 1 to 5 with the score of 5 representing the maximum positive or favorable response to each question. The following choices were included in each questionnaire:
- Strongly disagree
- Disagree
- Neutral
- Agree
- Strongly Agree
Responses of the individual scales were added to create a total score, which would include a possible total range of 5 to a maximum of 25 points. 25 is the maximum positive or favorable response. | | Posted | | Mean | Standard Deviation | units on a scale | | within 24 hours of device placement | | | | ID | Title | Description |
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| OG000 | Diagnostic (Radiofrequency-guided Localization) | Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag |
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| Secondary | Surgeon's Experience Using Radiofrequency Tag to Guide Resection Compared to Wire Localization as Measured by a Surgeon's Questionnaire | The surgeon's experience with image-guided placement of the RFID tag.This assessments was captured using Likert-type questionnaires. Individual question responses for the patient and physician questionnaires ranged from 1 to 5 with the score of 5 representing the maximum positive or favorable response to each question. The following choices were included in each questionnaire:
- Strongly disagree
- Disagree
- Neutral
- Agree
- Strongly Agree
Responses of the individual scales were added to create a total score, which would include a possible total range of 5 to a maximum of 25 points. 25 is the maximum positive or favorable response. | | Posted | | Mean | Standard Deviation | units on a scale | | within 24 hours of surgery | | | | ID | Title | Description |
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| OG000 | Diagnostic (Radiofrequency-guided Localization) | Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag |
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| Secondary | Volume (cm3), of Tissue Removed With Specimen With Tag (Not Including Shave Margins, if Taken) | Amount of tissue removed with radiofrequency tag. | | Posted | | Mean | Standard Deviation | CM3 | | at time of pathologic evaluation of surgical specimen, within 4 weeks of surgery | | | | ID | Title | Description |
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| OG000 | Diagnostic (Radiofrequency-guided Localization) | Patients undergo mammogram or ultrasound for image-guided placement of the radiofrequency tag within 30 days of surgery and then undergo radiofrequency-guided localization during surgery. Implanted Medical Device: Radiofrequency tag Mammography: Undergo mammogram for image-guided placement of radiofrequency tag Questionnaire Administration: Ancillary studies Radiofrequency-Guided Localization: Undergo radiofrequency-guided localization Ultrasonography: Undergo ultrasound for image-guided placement of radiofrequency tag |
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