Status:
COMPLETED
Evaluation of Safety and Performance of Intraoperative Detection of Light Signals During Electrosurgical Breast Cancer Resection
Lead Sponsor:
Erbe Elektromedizin GmbH
Conditions:
Breast Cancer
Resection Margin
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This monocentric early feasibility first in human study is intended to evaluate safety and performance of intraoperative detection of light signals during electrosurgical breast cancer resection. In ...
Eligibility Criteria
Inclusion
- Female patient with primary invasive breast cancer (NST or NST with DCIS component, including endocrine pretreatment according to standard of care therapy at the study site)
- Solid tumor size ≥ 15 mm at screening, on sonography imaging
- Breast conserving surgery
- ≥ 18 years of age
- Ability to provide written informed consent
Exclusion
- Neoadjuvant chemotherapy
- Bilateral breast conserving surgery
- Invasive lobular carcinoma, DCIS, LCIS
- Suspicion of extensive DCIS component of NST tumor
- Diagnosis of recurrent breast cancer
- Previous radiotherapy
- Patient is pregnant or lactating
- Patient is wearing active implant (cardiac pacemaker, internal defibrillator, other active implant), passive implants (hip arthroplasties, tooth implants etc.) are allowed at the discretion of the principal investigator
- According to physicians' assessment, patient is not able to follow study protocol (e.g., due to cognitive disease) or is not able to understand the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigation
Key Trial Info
Start Date :
September 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06020573
Start Date
September 26 2023
End Date
July 29 2024
Last Update
September 5 2024
Active Locations (1)
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1
Department for Women's Health
Tübingen, Germany, 72076