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EVA - Endoscopic Video-Assisted Nipple-Sparing Mastectomy (E-NSM): A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Signed informed consent

Locations
Other Locations
Italy
Istituto Europeo di Oncologia
RECRUITING
Milan
Contact Information
Primary
Eleonora Meduri, MD
eleonora.meduri@ieo.it
+39 02 57489 725
Time Frame
Start Date: 2026-05-23
Estimated Completion Date: 2027-07
Participants
Target number of participants: 10
Treatments
Experimental: Endoscopic video-assisted nipple-sparing mastectomy (E-NSM)
All enrolled patients will undergo endoscopic video-assisted nipple-sparing mastectomy (E-NSM) with immediate breast reconstruction (implant-based or pre-planned alternative reconstruction).
Related Therapeutic Areas
Sponsors
Leads: European Institute of Oncology

This content was sourced from clinicaltrials.gov