Actively Recruiting
Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy
Led by Alejandra García-Novoa · Updated on 2025-02-12
126
Participants Needed
1
Research Sites
478 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Non-inferiority study of video-assisted (endoscopic or robotic) skin- and nipple-sparing mastectomy compared to open mastectomy. The feasibility of the technique, oncological safety and cosmetic results will be studied.
CONDITIONS
Official Title
Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women who require a mastectomy and who do not require skin reduction or resection
- Women with breast cancer or at high risk for breast cancer
You will not qualify if you...
- Sarcomas of the breast
- Benign breast tumors
- Prepectoral reconstruction with expansion
- Inability to preserve the skin
- Need for reduction pattern
- Inability to perform MRI during follow-up (due to obesity, claustrophobia, etc.)
- Inability to complete the BREAST-Q questionnaire due to cognitive issues
- Patient refusal to participate in the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Breast Unit. First floor. Hospital Abente y Lago. Paseo del General Sir John Moore, 4
A Coruña, Galicia, Spain, 15006
Actively Recruiting
Research Team
A
Alejandra García Novoa, PhD MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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