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Endoscopic Video-Assisted Nipple-Sparing Mastectomy

RecruitingNAAges 18 Years - anyFemaleEuropean Institute of Oncology
NCT07579117 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) is an advancement in minimally invasive breast surgery designed to reduce surgical trauma and improve cosmetic outcomes while maintaining strict oncologic safety. The procedure will be carried out by a dedicated surgical team in which at least one operator holds certified laparoscopic surgical training issued by a recognized scientific society, ensuring appropriate technical expertise and adherence to surgical safety standards.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female patients aged ≥18 years * Candidates for nipple-sparing mastectomy (NSM) with immediate reconstruction * Histologically confirmed invasive carcinoma cT1N0, or carriers of pathogenic germline mutations undergoing prophylactic mastectomy * Breast size I-III and absence of significant glandular ptosis * Signed informed consent Exclusion Criteria: * Inflammatory breast cancer * Locally advanced clinical stage (cT2-T4 or N+) * Ductal carcinoma in situ (DCIS) without invasive component * Previous radiotherapy to the affected breast * Locoregional recurrence * Clinical conditions contraindicating prosthetic reconstruction * Indication for skin-sparing (SSM) or skin-reducing mastectomy (SRM) * Ongoing or completed neoadjuvant chemotherapy before surgery * Refusal or inability to sign informed consent * Inability to complete scheduled follow-up
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What it tests

  • Endoscopic video-assisted nipple-sparing mastectomy (E-NSM)
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Where

1 site
Istituto Europeo di Oncologia
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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