Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04750889
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2021-02-08
Brief Title:
Breast Localization RFID Tags vs Wire Localization
Sponsor:
Centre Jean Perrin
Organization:
Centre Jean Perrin
Study Overview
Official Title:
RFID Trial Localization of Non-palpable Breast Lesions Using Radiofrequency Identification Tags or Wire
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RFID
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 patients 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
Patients will fill in their questionnaire in two steps
during the installation of the device RFID tag or wire localization to evaluate the patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None