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Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy
RECRUITINGSponsored by Alejandra García-Novoa
Actively Recruiting
SponsorAlejandra García-Novoa
Started2025-02-01
Est. completion2029-04-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06823414
Summary
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.
Eligibility
Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
Inclusion Criteria: * Women who require a mastectomy and who do not require skin reduction or resection are included. Women with both breast cancer and those at high risk for breast cancer are included. Exclusion Criteria: * Sarcomas of the breast. * Benign breast tumors. * Prepectoral reconstruction with expansion. * Impossibility to preserve the skin. * Need for reduction pattern * Inability to perform an MRI during follow-up (obesity, claustrophobia, etc.). * Inability to complete the BREAST-Q™ questionnaire due to the patient's cognitive alterations. * Refusal of the patient to participate in the study.
Conditions5
Breast CancerBreast Cancer Early Stage Breast Cancer (Stage 1-3)Breast Cancer Non-invasive Breast CancerCancerHigh Risk Breast Carcinoma
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Actively Recruiting
SponsorAlejandra García-Novoa
Started2025-02-01
Est. completion2029-04-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06823414