RecruitingNot ApplicableNCT07507890

Endoscopic Nipple-Sparing Mastectomy Through a Single Axillary Incision in Breast Cancer

MINI-B - Minimally Invasive Endoscopic Mastectomy Using a Single Axillary Incision in Breast Cancer Patients: a Prospective Cohort Study


Sponsor

Fondazione del Piemonte per l'Oncologia

Enrollment

10 participants

Start Date

Jun 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This single-center prospective study will evaluate the feasibility and safety of endoscopic nipple-sparing mastectomy (E-NSM) performed through a single axillary incision in selected women with breast cancer undergoing direct-to-implant breast reconstruction. The study will assess procedural feasibility, completeness of resection, short-term postoperative complications, and patient-reported outcomes


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a minimally invasive surgical technique for breast cancer — a nipple-sparing mastectomy performed through a single small incision in the armpit, using an endoscope rather than a large open cut. The procedure is being studied in 10 women with early-stage breast cancer or ductal carcinoma in situ who are candidates for mastectomy with immediate implant reconstruction. Eligible women must be 18 or older, have small to medium-sized breasts, and not have had previous breast surgery, radiation, or active skin or nipple involvement. Participation involves undergoing the procedure and completing quality-of-life questionnaires at follow-up visits over 3 months. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEndoscopic Nipple-Sparing Mastectomy (E-NSM)

Endoscopic nipple-sparing mastectomy performed through a single extra-mammary axillary incision using a standardized minimally invasive surgical technique; immediate direct-to-implant reconstruction will be performed according to institutional practice.


Locations(1)

Breast Unit

Candiolo, Turin, Italy

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NCT07507890


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