Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID07292246

A Prospective Cohort Study of HandX-Assisted Endoscopic Nipple-Sparing Mastectomy: Feasibility and Safety (ATHENA I Study)

Led by Vasileios Kalles · Updated on 2025-12-18

15

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether the handheld robotic device called HandX can help surgeons perform minimally invasive nipple-sparing mastectomy safely and effectively. This procedure removes breast tissue through a small side incision while preserving the skin and nipple to reduce scarring and improve comfort and cosmetic results. The study focuses on patients planning therapeutic or preventive mastectomy with immediate implant-based reconstruction, conducted at Mediterraneo Hospital in Greece. The surgery uses the HandX device for endoscopic dissection through a single lateral mammary fold incision. After creating a working space with CO2 insufflation, the device assists in separating breast gland tissue from the skin and nipple area. Reconstruction is then completed with implant-based methods tailored to each patient. The study evaluates the ability to complete the surgery without switching to open surgery and monitors for complications, healing, and implant-related issues for up to one year. Participants will be assessed before and after surgery using the BREAST-Q questionnaire to report on comfort, well-being, and cosmetic satisfaction. Researchers will track surgical time, blood loss, hospital stay length, and complication rates. Follow-up visits occur through 28 days post-op, with additional infection checks through 90 days and implant monitoring for one year. Data is securely collected, with safety and technical success as primary outcomes to inform future larger trials.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female sex
  • Age 18 years or older
  • Indication for therapeutic or preventive mastectomy for early invasive breast cancer (Clinical Stage I-II), DCIS, BRCA or other breast cancer-related genetic mutations, or high breast cancer risk
  • Breast size between cup sizes A to C with expected implant volume less than 550cc
  • ECOG/WHO Performance Status less than 2
  • Signed and dated informed consent form
Not Eligible

You will not qualify if you...

  • Chest wall or skin invasion
  • Extended lymph node involvement at diagnosis (cN2)
  • Inflammatory breast cancer
  • Tumor less than 1 cm from nipple-areola complex on imaging
  • Active smoking or nicotine use within 4 weeks before surgery
  • Body mass index greater than 35
  • Severe uncontrolled co-morbid conditions such as diabetes, heart disease, renal failure, or liver dysfunction
  • Pregnancy or breastfeeding
  • Psychiatric, addictive, or other disorders affecting ability to consent
  • No signed informed consent form

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - Hospital stay of approximately 1 to 3 days

Participants undergo HandX-assisted endoscopic nipple-sparing mastectomy with immediate implant-based breast reconstruction. The procedure includes a single lateral mammary fold incision, endoscopic dissection using the HandX device, and implant reconstruction according to standard practice.

1 surgical hospitalization visit

Post-operative Follow-up

Duration - Up to 1 year

Participants are monitored for surgical safety and recovery, including assessment of complications, surgical site infections, and implant-related outcomes. Follow-up includes visits up to 28 days post-surgery, additional infection surveillance through 90 days, and implant outcome assessments through one year.

Approximately 3 visits within 30 days, additional visits for infection surveillance through 90 days, and follow-up visits at 6 and 12 months

Trial Site Locations

Total: 1 location

1

Mediterraneo Hospital

Glyfada, Attica, Greece, 16675

Actively Recruiting

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Research Team

V

Vasileios Kalles, MD, MSc, PhD, FEBS

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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Published Research Related To This Trial

Robotic Nipple-sparing Mastectomy and Immediate Breast Reconstruction With Implant: First Report of Surgical Technique.

Antonio Toesca, Nickolas Peradze, Viviana Galimberti...

https://pubmed.ncbi.nlm.nih.gov/28692558

Revolutionising Breast Surgery: A Comprehensive Review of Robotic Innovations in Breast Surgery and Reconstruction.

Yashraj Jain, Ranjana Lanjewar, Raju K Shinde

https://pubmed.ncbi.nlm.nih.gov/38384645

Minimally Invasive Mastectomy Could Achieve Non-inferior Oncological Outcome in Appropriately Selected Patients: Propensity Matched Analysis of the National Cancer Database.

Lifen Cao, Robert Shenk, Megan E Miller...

https://pubmed.ncbi.nlm.nih.gov/33861667