RFID Trial: Localization of Non-palpable Breast Lesions Using Radiofrequency Identification Tags or Wire
| Registry | NCT04750889, acronym RFID |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 80 (Actual) |
| Sponsor | Centre Jean Perrin (Other) |
| Conditions | Breast Neoplasm Female |
| Interventions | RFID tags, Wire localization (Device) |
| Dates | start 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 in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Breast Neoplasm Female All trials of RFID tags All trials of Wire localization
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| RFID tags localization | Device: RFID tags | ||
| Wire localization | Device: Wire localization |
Sex: Female, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Centre Jean PERRIN | Clermont-Ferrand | France |