Endoscopic nipple-sparing mastectomy with video guidance
Official title: EVA - Endoscopic Video-Assisted Nipple-Sparing Mastectomy (E-NSM): A Pilot Study
Run by European Institute of Oncology · NCT07579117 · Data updated 2026-11-12
This study tests a minimally invasive nipple-sparing mastectomy using endoscopic video guidance to see if it is feasible and safe for appropriately selected breast cancer patients and prophylactic risk carriers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 10 (estimated) |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | May 23, 2026 |
| Main results expected | April 2027 |
| Study ends | July 2027 |
| Registry record updated | June 1, 2026 |
| Trial ID | NCT07579117 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult female patients eligible for nipple-sparing mastectomy with immediate reconstruction, including those with small-to-moderate breast size, no significant ptosis, and either invasive cancer (cT1N0) or carriers of pathogenic germline mutations undergoing prophylactic mastectomy.
✕Probably not a fit
Patients with inflammatory breast cancer, locally advanced disease, DCIS without invasion, prior breast radiotherapy, recurrence, contraindications to reconstruction, or inability to complete follow-up may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study prospectively documents the technical feasibility and perioperative outcomes of an endoscopic video-assisted nipple-sparing mastectomy performed per a standardized institutional protocol. It includes perfusion assessment with indocyanine green angiography and patient-reported outcomes via the BREAST-Q. The goal is to refine the protocol and inform design for future comparative or multicenter trials. Procedures are performed by a surgical team with certified laparoscopic training to maintain safety and quality standards. Data collected will focus on surgical feasibility, safety, cosmetic results, and patient experience.
Why it matters
Potential benefit: If successful, patients may experience reduced surgical trauma and improved cosmetic outcomes without compromising oncologic safety.
How similar studies have gone: Limited prior data exist on endoscopic nipple-sparing approaches; this pilot aims to establish feasibility and safety to inform broader studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Istituto Europeo di Oncologia
Milan, Italy Recruiting
Study contacts
- Study coordinator: Eleonora Meduri, MD
- Email: eleonora.meduri@ieo.it
- Phone: +39 02 57489 725
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.