HandX-assisted endoscopic nipple-sparing mastectomy (ATHENA I)

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

This study tests whether a handheld robotic device called HandX can help surgeons safely perform a minimally invasive nipple-sparing mastectomy with immediate implant reconstruction for women having therapeutic or risk-reducing mastectomy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Mediterraneo Hospital (other)
• Locations: 1 site (Glyfada, Attica)
• Trial ID: NCT07292246 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-center, single-arm trial using the HandX handheld articulating robotic instrument to assist endoscopic nipple-sparing mastectomy through a single lateral mammary fold incision with immediate implant-based reconstruction. Surgeons create a working space with tumescent injection and CO₂ insufflation via a single-port device, then use HandX for dissection, specimen retrieval, and reconstruction via standard implant techniques. The study records operative time, ability to complete the planned endoscopic approach without conversion to open surgery, and perioperative complications, with clinical follow-up for surgical healing, infections, and implant-related issues for up to 365 days. The goal is to determine the feasibility and safety of using the HandX system specifically in endoscopic breast surgery where improved instrument articulation may aid dissection and ergonomics.

Who should consider this trial

Good fit: Women aged 18 or older planning a therapeutic or prophylactic nipple-sparing mastectomy with immediate implant-based reconstruction, with breast cup size A–C, expected implant volume under 550 cc, ECOG performance status <2, and who consent to single-center surgery and follow-up.

Not a fit: Patients with chest wall or skin invasion, inflammatory or locally advanced disease, extensive nodal involvement, tumors too close to the nipple-areola complex, very large breasts or advanced ptosis are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, this approach could reduce visible scarring and improve comfort and cosmetic outcomes after nipple-sparing mastectomy while maintaining surgical safety.

How similar studies have performed: Handheld articulating instruments have shown encouraging ergonomics and access in other surgical specialties, but their use for endoscopic nipple-sparing mastectomy is novel and supported by limited clinical data.

Eligibility criteria

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

Where this trial is running

Glyfada, Attica

• Mediterraneo Hospital — Glyfada, Attica, Greece (RECRUITING)

Study contacts

• Principal investigator: Vasileios Kalles, MD, MSc, PhD, FEBS — Mediterraneo Hospital
• Study coordinator: Vasileios Kalles, MD, MSc, PhD, FEBS

Conditions: Breast Cancer, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation, Hereditary Breast Carcinoma, Breast Neoplasms, DCIS, Germline Mutation Abnormality, Early Breast Cancer