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Endoscopic Nipple-Sparing Mastectomy Through a Single Axillary Incision in Breast Cancer
RECRUITINGN/ASponsored by Fondazione del Piemonte per l'Oncologia
Actively Recruiting
PhaseN/A
SponsorFondazione del Piemonte per l'Oncologia
Started2025-06-11
Est. completion2026-06-30
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07507890
Summary
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
Eligibility
Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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
Conditions3
Breast CancerBreast Cancer - Ductal Carcinoma in Situ (DCIS)Cancer
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Actively Recruiting
PhaseN/A
SponsorFondazione del Piemonte per l'Oncologia
Started2025-06-11
Est. completion2026-06-30
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07507890