Actively Recruiting
A Prospective CohorT Study of HandX - Assisted ENdoscopic MAstectomy: Feasibility and Safety (ATHENA I Study)
Led by Vasileios Kalles · Updated on 2025-12-18
15
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective CohorT Study of HandX - Assisted ENdoscopic MAstectomy: Feasibility and Safety (ATHENA I Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female sex
- Age 18 years or older
- Indication for therapeutic or prophylactic mastectomy for early invasive breast cancer (Stage I-II) undergoing primary surgery
- Indication for therapeutic or prophylactic mastectomy for early invasive breast cancer (Stage I-II) after neoadjuvant therapy with partial or complete response
- Indication for therapeutic or prophylactic mastectomy for ductal carcinoma in situ (DCIS)
- Indication for therapeutic or prophylactic mastectomy for BRCA or other breast cancer-related genetic mutation carriers
- Indication for therapeutic or prophylactic mastectomy for high risk of developing breast cancer
- Breast volume cup sizes A to C, expected implant volume less than 550cc, and glandular ptosis not exceeding Grade I Regnault's classification
- ECOG or WHO performance status less than 2
- Signed and dated informed consent form
You will not qualify if you...
- Chest wall or skin invasion
- Extended lymph node involvement at diagnosis (cN2)
- Inflammatory breast cancer
- Tumor distance from nipple-areola complex less than 1 cm on imaging
- Active smoking or nicotine use within 4 weeks before surgery
- Body mass index greater than 35
- Severe and poorly controlled co-morbid conditions such as diabetes, heart disease, renal failure, or liver dysfunction
- Pregnancy or breastfeeding
- Psychiatric, addictive, or other disorders compromising ability to consent
- No signed and dated informed consent form
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mediterraneo Hospital
Glyfada, Attica, Greece, 16675
Actively Recruiting
Research Team
V
Vasileios Kalles, MD, MSc, PhD, FEBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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