The RFID trial focuses on breast localization in patients with non-palpable breast cancers. It aims to demonstrate the improvement in patient comfort when using the Radio Frequency Identification (RFID) tag and LOCalizer™ device compared to the gold standard device.
It is an observational, prospective, single-center, 2-arm (RFID group vs. standard gold), non-randomized and category 3 comparative study. The RFID trial focuses on breast localization in patients with non-palpable breast cancers. These patients will benefit from a mastology consultation: consent will then be acquired. The RFID tag or the gold standard localization will be put in place during this consultation (one day before surgery). Patients will fill in their questionnaire in two steps: * during the installation of the device (RFID tag or wire localization) to evaluate the patient's pain, * then at the 1-month post-operative consultation to assess pain in the interval until surgery Radiologists and surgeons will fill out the questionnaire dedicated to them after each procedure.
Study Type
OBSERVATIONAL
Enrollment
80
Installation of the RFID tag device wire localization)
Installation of the wire localization device
Centre Jean PERRIN
Clermont-Ferrand, France
Evaluation of the patients satisfaction
The value of the satisfaction score of the patient questionnaire from 0 (worst statisfaction) to 10 (better statisfaction)
Time frame: 1 years and 1 month
Satisfaction of surgeons and radiologists assessed by a questionnaire
overall score values from the surgeon and radiologist questionnaires
Time frame: 1 years and 1 month
Evaluation of the quality of the RFID tag device by analizing surgery data
the occurrence or not of a migration of the RFID tag, histological data, the invasion of the margins and the rate of reoperation
Time frame: 1 years and 1 month
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