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Clinical Trial Summary

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 LOCalizerâ„¢ device compared to the gold standard device.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT04750889
Study type Observational
Source Centre Jean Perrin
Contact
Status Completed
Phase
Start date May 15, 2021
Completion date April 24, 2023

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