Clinical trial · Interventional
Endoscopic Video-Assisted Nipple-Sparing Mastectomy
EVA - Endoscopic Video-Assisted Nipple-Sparing Mastectomy (E-NSM): A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Surgery | — | UNRESOLVED | — |
| Endoscopic Video-assisted Nipple-sparing Mastectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endoscopic video-assisted nipple-sparing mastectomy (E-NSM)
- description
- All enrolled patients will undergo endoscopic video-assisted nipple-sparing mastectomy (E-NSM) with immediate breast reconstruction (implant-based or pre-planned alternative reconstruction).
- interventionNames
- Procedure: Endoscopic video-assisted nipple-sparing mastectomy (E-NSM)
Primary outcomes (3)
- measure
- Rate of completion of the procedure endoscopically without conversion to open surgery.
- timeFrame
- At surgery
- description
- Number of procedure not converted to open surgery on the total of study procedures.
- measure
- Surgery time
- timeFrame
- At surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available