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Spots Global Cancer Trial Database for Breast Localization: RFID Tags vs Wire Localization

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Trial Identification

Brief Title: Breast Localization: RFID Tags vs Wire Localization

Official Title: RFID Trial: Localization of Non-palpable Breast Lesions Using Radiofrequency Identification Tags or Wire

Study ID: NCT04750889

Study Description

Brief 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 LOCalizer™ device compared to the gold standard device.

Detailed 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Centre Jean PERRIN, Clermont-Ferrand, , France

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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