A Prospective CohorT Study of HandX - Assisted ENdoscopic MAstectomy: Feasibility and Safety (ATHENA I Study)
Recruiting
N/A
Interventional Study
Breast Cancer
BRCA 1 Gene Mutation
BRCA 2 Gene Mutation
Hereditary Breast Carcinoma
Breast Neoplasms
DCIS
Germline Mutation Abnormality
Early Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 15 (estimated)
- Sponsor
- Vasileios Kalles · Other
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About This Trial
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.
Par…
Trial Locations
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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) un…
Contacts