Breast Localization: RFID Tags vs Wire Localization

Centre Jean Perrin

Status

Completed

Conditions

Breast Neoplasm Female

Treatments

Device: Wire localization

Device: RFID tags

Study type

Observational

Funder types

Other

Identifiers

NCT04750889

RFID

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients 18 years of age or older,
Requiring conservative surgical management for a breast lesion -infra-clinical (fibroadenomas, papillomas, atypical lesions, neoplasia), whose histology will have been proven beforehand by anatomopathology.
Patients referred to mastology for preoperative identification by the surgeons
Able to give informed consent to participate in the research.
Affiliation to a Social Security regime

Exclusion criteria