NCT04750889

Breast Localization: RFID Tags vs Wire Localization

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Centre Jean Perrin · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasm Female

Interventions

Type	Name	Description
DEVICE	RFID tags	Installation of the RFID tag device wire localization)
DEVICE	Wire localization	Installation of the wire localization device

Timeline

• Start date: 2021-05-15
• Primary completion: 2023-04-24
• Completion: 2023-04-24
• First posted: 2021-02-11
• Last updated: 2023-06-18

Locations

1 site across 1 country: France