Study of HandX-Assisted Minimally Invasive Nipple-Sparing Mastectomy Safety and Effectiveness with Immediate Implant Reconstruction

What this Trial Is About

Researchers are investigating whether the handheld robotic device called HandX can help surgeons perform minimally invasive nipple-sparing mastectomy safely and effectively. This procedure removes breast tissue through a small side incision while preserving the skin and nipple to reduce scarring and improve comfort and cosmetic results. The study focuses on patients planning therapeutic or preventive mastectomy with immediate implant-based reconstruction, conducted at Mediterraneo Hospital in Greece. The surgery uses the HandX device for endoscopic dissection through a single lateral mammary fold incision. After creating a working space with CO2 insufflation, the device assists in separating breast gland tissue from the skin and nipple area. Reconstruction is then completed with implant-based methods tailored to each patient. The study evaluates the ability to complete the surgery without switching to open surgery and monitors for complications, healing, and implant-related issues for up to one year. Participants will be assessed before and after surgery using the BREAST-Q questionnaire to report on comfort, well-being, and cosmetic satisfaction. Researchers will track surgical time, blood loss, hospital stay length, and complication rates. Follow-up visits occur through 28 days post-op, with additional infection checks through 90 days and implant monitoring for one year. Data is securely collected, with safety and technical success as primary outcomes to inform future larger trials.

A Prospective CohorT Study of HandX - Assisted ENdoscopic MAstectomy: Feasibility and Safety (ATHENA I Study)