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

Summary

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. During the operation, surgeons use the HandX device to assist with the endoscopic dissection. Researchers will collect information about how long the surgery takes, whether the planned approach can be completed without switching to open surgery, and whether any surgical complications occur. They will also check healing, infection, and implant-related problems for up to 365 days after surgery. Participants will complete the BREAST-Q questionnaire before surgery and at several times after surgery to share their views on comfort, well-being, and cosmetic outcomes. About 15 participants will take part. The results will help researchers understand whether this approach is practical and safe, and whether it should be studied further in a larger trial.

Eligibility

Inclusion Criteria:

* Female sex
* Age ≥ 18 years old
* Indication for therapeutic or prophylactic (risk-reducing) mastectomy for:

  1. early invasive breast cancer (Clinical Stage I-II at diagnosis) undergoing primary surgery
  2. early invasive breast cancer (Clinical Stage I-II at diagnosis) undergoing surgery post systemic (neoadjuvant) therapy with clinical evidence of partial or complete response
  3. ductal carcinoma in situ (DCIS), or
  4. BRCA or other breast cancer - related genetic mutation carriers, or
  5. high risk for development of breast cancer.
* Breast volume: cup sizes A to C as defined by underwear size, expected implant volume \<550cc and glandular ptosis not exceeding Grade I Regnault's classification.
* ECOG / WHO Performance Status \<2
* Subject with signed and dated informed consent form

Exclusion Criteria:

* Chest wall or skin invasion
* Extended lymph node involvement at diagnosis (cN2)
* Inflammatory breast cancer
* Tumor distance from nipple - areola complex \<1cm on imaging studies
* Active smoking/nicotine use within 4 weeks pre-op (combustible tobacco, vaping, nicotine pouches, NRT)
* BMI \>35
* High risk patients with severe and poorly controlled co-morbid conditions (including but not limited to diabetes, heart disease, renal failure or liver dysfunction)
* Pregnancy or breastfeeding
* Psychiatric, addictive, or any disorders which compromise the ability to give informed consent for participation in this study
* Subject without signed and dated informed consent form

Conditions9

Browse More Trials