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Tests treatment safety and results for Breast Cancer
Official title A Prospective CohorT Study of HandX - Assisted ENdoscopic MAstectomy: Feasibility and Safety (ATHENA I Study)
ClinicalTrials.gov ID: NCT07292246
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Female sex
- Age ≥ 18 years old
- Indication for therapeutic or prophylactic (risk-reducing) mastectomy for:
- early invasive breast cancer (Clinical Stage I-II at diagnosis) undergoing primary surgery
- early invasive breast cancer (Clinical Stage I-II at diagnosis) undergoing surgery post systemic (neoadjuvant) therapy with clinical evidence of...
You likely can't join if
- 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
See the full eligibility criteria
- Female sex
- Age ≥ 18 years old
- Indication for therapeutic or prophylactic (risk-reducing) mastectomy for:
- early invasive breast cancer (Clinical Stage I-II at diagnosis) undergoing primary surgery
- early invasive breast cancer (Clinical Stage I-II at diagnosis) undergoing surgery post systemic (neoadjuvant) therapy with clinical evidence of partial or complete response
- ductal carcinoma in situ (DCIS), or
- BRCA or other breast cancer - related genetic mutation carriers, or
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Glyfada, Attica, Greece
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glyfada, Attica, Greece. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.