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NCT04750889 | COMPLETED | Breast Neoplasm Female

Breast Localization: RFID Tags vs Wire Localization
Sponsor:

Jean Perrin Center

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.

Condition or disease

Breast Neoplasm Female

Intervention/treatment

RFID tags

Wire localization

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 80 participants
Official Title : RFID Trial: Localization of Non-palpable Breast Lesions Using Radiofrequency Identification Tags or Wire
Actual Study Start Date : 2021-05-15
Estimated Primary Completion Date : 2023-04-24
Estimated Study Completion Date : 2023-04-24

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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
  • * Multiple breast lesions
  • * Patients with breast neoplasia during pregnancy.
  • * Person deprived of liberty or under guardianship or incapable of giving consent
  • * Refusal to participate
Breast Localization: RFID Tags vs Wire Localization

Location Details

NCT04750889

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

France,

Jean PERRIN Center

Clermont-Ferrand, France, 63011