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

RecruitingNAAges 18 Years - anyFemaleVasileios Kalles
NCT07292246 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 wi

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📋 Eligibility rules (as published)
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
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What it tests

  • Endoscopic nipple sparing mastectomy
  • HandX endoscopic instrument
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Where

1 site
Mediterraneo Hospital
Glyfada, Greece
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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