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EndoBreast Study - Assessment of Feasibility, Functional Outcomes, and Sensitivity of the Areola-Nipple Complex in Endoscopic Mastectomy

Recruitingn/aAges 18 Years - 75 YearsFemaleMassimiliano Bortolini
NCT07718425 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Study Design Prospective, single-center, observational, non-interventional study conducted in routine clinical practice. No investigational treatments or modifications to standard diagnostic, therapeutic, or follow-up procedures are planned. Consecutive eligible patients undergoing endoscopic nipple-sparing mastectomy (NSM) with immediate breast reconstruction will be prospectively enrolled. Background and Rationale Nipple-sparing mastectomy with immediate reconstruction is an established treatment for selected patients with breast cancer and women undergoing prophylactic mastectomy because of hereditary risk. Preservation of the nipple-areola complex (NAC) improves cosmetic outcomes, body image, and patient satisfaction while maintaining oncological safety. Endoscopic NSM is a minimally invasive alternative that may reduce scarring, surgical trauma, and recovery time while improving ae

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📋 Eligibility rules (as published)
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.
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What it tests

  • endoscopic mastectomy
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Where

1 site
Ospedale degli Infermi ASL BI
Ponderano, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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