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

NCT07292246 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-18

No results posted yet for this study

Summary

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

  • Breast Cancer
  • BRCA 1 Gene Mutation
  • BRCA 2 Gene Mutation
  • Hereditary Breast Carcinoma
  • Breast Neoplasms
  • DCIS
  • Germline Mutation Abnormality
  • Early Breast Cancer

Interventions

PROCEDURE

Endoscopic nipple sparing mastectomy

A minimally invasive nipple-sparing mastectomy performed through a single lateral mammary fold incision using endoscopic visualization and CO₂ insufflation. Breast tissue is dissected from the skin envelope and nipple-areola complex, and immediate implant-based reconstruction is performed according to standard practice. The HandX device is used for articulating endoscopic dissection.

DEVICE

HandX endoscopic instrument

A handheld articulating endoscopic instrument used to assist with endoscopic dissection during nipple-sparing mastectomy. The HandX device provides wrist-like articulation, motion scaling, and ergonomic control during minimally invasive surgery.

Sponsors & Collaborators

  • Vasileios Kalles

    lead OTHER

Principal Investigators

  • Vasileios Kalles, MD, MSc, PhD, FEBS · Mediterraneo Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-09
Primary Completion
2028-10-31
Completion
2029-10-31

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07292246 on ClinicalTrials.gov