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

This study aims to learn whether a handheld robotic device, called the HandX, can help surgeons safely perform a minimally invasive nipple-sparing mastectomy. This type of mastectomy uses a small incision at the side of the breast to remove breast tissue while keeping the skin and nipple in place. The goal is to lower scarring, improve comfort, and support good cosmetic results after surgery. Participants in this study will already be planning to have a therapeutic or preventive mastectomy with immediate implant-based reconstruction. All surgeries are done at Mediterraneo Hospital in Greece.

Trial Details

NCT ID
NCT07292246
Phase
NA
Sponsor
Vasileios Kalles
Status
RECRUITING
Cancer Type
Lobular Carcinoma Breast Cancer
Interventions
  • Endoscopic nipple sparing mastectomy
  • HandX endoscopic instrument
Locations (sample)
  • Glyfada, Attica, Greece|37.86289,23.75802

Key Eligibility Criteria

  • Female sex
  • Age ≥ 18 years old
  • Indication for therapeutic or prophylactic (risk-reducing) mastectomy for:
  • early invasive breast cancer (Clinical Stage I-II at diagnosis) undergoing primary surgery

For full eligibility, visit ClinicalTrials.gov.

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