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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: vassilis_kalles@yahoo.gr
• Phone: 00306973746477

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using nanoparticles for delayed lymph node biopsy in breast cancer patients

  This study is testing if using special nanoparticles can help breast cancer patients avoid unnecessary surgery by identifying important lymph nodes only when needed.

  Recruiting at 9 sites Phase 3 Uppsala University · Houston, Texas and 8 other locations · NCT04722692

• ATUSA 3D automated breast ultrasound for suspicious breast lesions

  This study will test whether the ATUSA 3D automated breast ultrasound system can produce high-quality images that match biopsy results in women with BI-RADS 4 or 5 breast findings.

  Recruiting at 2 sites iSono Health, Inc. · Sacramento, California and 1 other locations · NCT07505797

• Prehabilitation plus ongoing exercise and nutrition support for women with breast cancer

  This trial will test whether a short supervised pre-treatment program of high-intensity exercise and personalized nutrition followed by home-based exercise and dietary guidance helps newly diagnosed women with stage 0–III breast cancer recover better and tolerate treatment.

  Recruiting at 2 sites European University Miguel de Cervantes · Valladolid, Valladolid and 1 other locations · NCT07467824

• Adherence to Cell Cycle Inhibitors with Endocrine Therapy in Localized High-Risk ER+ Breast Cancer

  This study checks how well patients with localized ER+ breast cancer stick to a combined endocrine therapy and CDK4/6 inhibitor after surgery.

  Recruiting University Hospital, Grenoble · Grenoble · NCT07443774

• Capecitabine with or without elacestrant for ER-positive advanced breast cancer

  This trial will try adding elacestrant to capecitabine to see if it helps people with ER-positive, HER2-negative advanced breast cancer that stopped responding to CDK4/6 inhibitors.

  Recruiting Phase 2 Dana-Farber Cancer Institute · Boston, Massachusetts · NCT07222215

• Radiology-based prediction of HER2 level and T‑DXd benefit in metastatic breast cancer

  This study tests whether patterns in CT or FDG‑PET images can show HER2 level and help predict response to trastuzumab deruxtecan for people with metastatic breast cancer.

  Recruiting Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Milan · NCT07030569

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.