Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07507890

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

Led by Fondazione del Piemonte per l'Oncologia · Updated on 2026-04-02

10

Participants Needed

1

Research Sites

81 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Breast Unit

Candiolo, Turin, Italy, 10060

Actively Recruiting

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Research Team

A

Antonio Toesca, MD

CONTACT

G

Giada Pozzi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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