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

Recruiting now · Not applicable

Conditions studied: Breast Cancer - Ductal Carcinoma in Situ (DCIS), Breast Cancer

In brief

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

Key facts

Study ID

NCT07507890

Run by

Fondazione del Piemonte per l'Oncologia

People needed

10

Starts

2025-06-11

Expected to finish

2026-12-30

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Breast Unit — Candiolo, Turin, Italy (enrolling)

Full record on ClinicalTrials.gov

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