- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04750889
Breast Localization: RFID Tags vs Wire Localization (RFID)
RFID Trial: Localization of Non-palpable Breast Lesions Using Radiofrequency Identification Tags or Wire
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Hugo Veyssière
- Phone Number: 04 73 27 80 05
- Email: hugo.veyssiere@clermont.unicancer.fr
Study Locations
-
-
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Clermont-Ferrand, France, 63011
- Centre Jean Perrin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
RFID tags localization
|
Installation of the RFID tag device wire localization)
|
Wire localization
|
Installation of the wire localization device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the patients satisfaction
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)
|
1 years and 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction of surgeons and radiologists assessed by a questionnaire
Time Frame: 1 years and 1 month
|
overall score values from the surgeon and radiologist questionnaires
|
1 years and 1 month
|
Evaluation of the quality of the RFID tag device by analizing surgery data
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
|
1 years and 1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RFID
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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