Endoscopic Video-Assisted Nipple-Sparing Mastectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEuropean Institute of Oncology
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Endoscopic video-assisted nipple-sparing mastectomy (E-NSM)
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov