EndoBreast: Feasibility and outcomes of nipple-sparing endoscopic mastectomy with immediate reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, non-interventional study conducted in routine clinical practice. Consecutive eligible women undergoing endoscopic nipple-sparing mastectomy with immediate reconstruction are enrolled to observe feasibility, functional outcomes of the areola-nipple complex, and patient satisfaction. No experimental treatments or changes to standard care are planned. The study aims to describe how well the procedure preserves NAC function and aesthetics in a real-world setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female; age 18-75 years;
* indication for prophylactic or therapeutic NSM;
* breast volume suitable for endoscopic surgery;
* Regnault ptosis ≤ Grade II;
* eligibility for immediate implant-based reconstruction;
* WHO/ECOG performance status \<3;
* written informed consent.

Exclusion Criteria:

* Inflammatory breast cancer or skin involvement;
* previous breast cancer surgery or radiotherapy to the affected breast;
* BMI \>35 kg/m²; active smoking; ASA Physical Status \>2;
* pregnancy or breastfeeding;
* inability to provide informed consent;
* participation in incompatible interventional clinical trials.

Where it's running

• Ospedale degli Infermi ASL BI
  Ponderano, Bi, Italy Recruiting

Study contacts

• Study coordinator: Massimiliano Bortolini, MD
• Email: massimiliano.bortolini@aslbi.piemonte.it
• Phone: 003901515156616

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.