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NCT Number: NCT07579117

Endoscopic Video-Assisted Nipple-Sparing Mastectomy

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.

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Key information

Conditions

Endoscopic Video-assisted Nipple-sparing Mastectomy Breast Cancer Breast Diseases Breast Neoplasms Breast Surgery Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location status: Recruiting

Location contact

Eleonora Meduri, MD

CONTACT

[email protected]

+39 02 57489 725

Eleonora Meduri, MD

PRINCIPAL_INVESTIGATOR

About this study

This pilot study aims to prospectively document the technical feasibility and perioperative outcomes of E-NSM performed according to an established institutional protocol, including standardized perfusion assessment using indocyanine green (ICG) angiography and patient-reported outcomes using BREAST-Q questionnaire. Data generated from this study will support refinement of the institutional protocol and inform the design of future comparative or multicentre trials.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Locoregional recurrence
  • Clinical conditions contraindicating prosthetic reconstruction
  • Indication for skin-sparing (SSM) or skin-reducing mastectomy (SRM)
  • Ongoing or completed neoadjuvant chemotherapy before surgery
  • Refusal or inability to sign informed consent
  • Inability to complete scheduled follow-up

Treatment and study plan

Endoscopic video-assisted nipple-sparing mastectomy (E-NSM)

Procedure

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. Recent prospective studies and meta-analyses have shown encouraging results in terms of technical feasibility, reduced flap-related complications, and higher patient satisfaction compared with the conventional open approach.

Primary outcomes

  1. Rate of completion of the procedure endoscopically without conversion to open surgery.

    Time frame: At surgery

    Number of procedure not converted to open surgery on the total of study procedures.

  2. Surgery time

    Time frame: At surgery

    Average and median duration of endoscopic dissection, including creation of the working space.

  3. Feasibility of immediate reconstruction

    Time frame: At surgery

    The feasibility and type of immediate reconstruction performed (direct-to-implant or two stage) measured as the number immediate rescotruction on the number of total surgery performed.

Study contacts

Contact information is provided by the study sponsor or research team.

Eleonora Meduri, MD

CONTACT

[email protected]

+39 02 57489 725

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

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

Acronym: EVA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 11, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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