Centre Jean PERRIN
Clermont-Ferrand, 63011, France
NCT Number: NCT04750889
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.
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Female
Observational
Clermont-Ferrand, 63011, France
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Installation of the RFID tag device wire localization)
Installation of the wire localization device
Time frame: 1 years and 1 month
The value of the satisfaction score of the patient questionnaire from 0 (worst statisfaction) to 10 (better statisfaction)
Time frame: 1 years and 1 month
overall score values from the surgeon and radiologist questionnaires
Time frame: 1 years and 1 month
the occurrence or not of a migration of the RFID tag, histological data, the invasion of the margins and the rate of reoperation
Centre Jean Perrin
Other
RFID Trial: Localization of Non-palpable Breast Lesions Using Radiofrequency Identification Tags or Wire
Acronym: RFID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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