NCT07579117

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
May 2026Jul 2027

First Submitted

Initial submission to the registry

April 30, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

May 23, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

June 1, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

April 30, 2026

Last Update Submit

May 28, 2026

Conditions

Endoscopic Video-assisted Nipple-sparing MastectomyBreast SurgeryBreast Cancer

Outcome Measures

Primary Outcomes (3)

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

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

    At surgery

  • Surgery time

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

    At surgery

  • Feasibility of immediate reconstruction

    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.

    At surgery

Study Arms (1)

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

EXPERIMENTAL

All enrolled patients will undergo endoscopic video-assisted nipple-sparing mastectomy (E-NSM) with immediate breast reconstruction (implant-based or pre-planned alternative reconstruction).

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

Interventions

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.

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Eleonora Meduri, MD

CONTACT

+39 02 57489 725eleonora.meduri@ieo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 11, 2026

Study Start

May 23, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

June 1, 2026

Record last verified: 2026-04

Locations

IT(1)