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Endoscopic Nipple-Sparing Mastectomy Through a Single Axillary Incision in Breast Cancer

RecruitingNAAges 18 Years - anyFemaleFondazione del Piemonte per l'Oncologia
NCT07507890 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This single-center prospective study will evaluate the feasibility and safety of endoscopic nipple-sparing mastectomy (E-NSM) performed through a single axillary incision in selected women with breast cancer undergoing direct-to-implant breast reconstruction. The study will assess procedural feasibility, completeness of resection, short-term postoperative complications, and patient-reported outcomes

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female participants aged 18 years or older. * Diagnosis of early-stage invasive breast cancer or ductal carcinoma in situ, including multifocal or multicentric disease. * Candidate for nipple-sparing mastectomy with immediate direct-to-implant reconstruction. * Small- to medium-sized breasts with ptosis grade 2 or less. * Written informed consent provided. Exclusion Criteria: * Preoperative evidence of skin involvement, nipple-areola complex involvement, lymph-node metastases, inflammatory breast cancer, Paget's disease, mesenchymal breast tumors, or recurrent breast cancer. * Previous ipsilateral breast surgery. * Previous thoracic radiation therapy. * Heavy smoking (\>20 cigarettes/day), uncontrolled diabetes mellitus, or body mass index \>30. * ASA score 3 or higher. * Ongoing pregnancy
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What it tests

  • Endoscopic Nipple-Sparing Mastectomy (E-NSM)
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Where

1 site
Breast Unit
Candiolo, 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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