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

NCT07292246 | Recruiting

• 1 other identifier: 516
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

breast cancer; mastectomy; endoscopic; robotic; handx; nipple-sparing mastectomy

Outcome Measures

Primary Outcomes (2)

• Technical success

  Completion of the planned procedure via the minimally invasive approach without unplanned conversion.

  Intraoperative (Day 0)

• Surgical Safety

  Major (Clavien-Dindo ≥III) complications

  Postoperative Day 0-30

Secondary Outcomes (10)

• Operative Time

  Intraoperative (Day 0)

• Blood Loss

  Intraoperative (Day 0)

• Length of Stay

  From hospitalization to discharge (average 1-3 days)

• Complications

  Within 30 days after surgery

• Skin flap necrosis

  Within 30 days after surgery

Study Arms (1)

HandX-assisted endoscopic nipple sparing mastectomy

EXPERIMENTAL

Patient cohort undergoing endoscopic nipple sparing mastectomy with use of HandX.

Procedure: Endoscopic nipple sparing mastectomy; Device: HandX endoscopic instrument

Interventions

Endoscopic nipple sparing mastectomy PROCEDURE

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.

HandX-assisted endoscopic nipple sparing mastectomy

HandX endoscopic instrument DEVICE

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.

HandX-assisted endoscopic nipple sparing mastectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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
• 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

Sponsors & Collaborators

• Vasileios Kalles: lead

Study Sites (1)

Mediterraneo Hospital

Glyfada, Attica, 16675, Greece

RECRUITING

Related Publications (7)

• Toesca A, Peradze N, Galimberti V, Manconi A, Intra M, Gentilini O, Sances D, Negri D, Veronesi G, Rietjens M, Zurrida S, Luini A, Veronesi U, Veronesi P. Robotic Nipple-sparing Mastectomy and Immediate Breast Reconstruction With Implant: First Report of Surgical Technique. Ann Surg. 2017 Aug;266(2):e28-e30. doi: 10.1097/SLA.0000000000001397. No abstract available.

  PMID: 28692558 BACKGROUND

• Jain Y, Lanjewar R, Shinde RK. Revolutionising Breast Surgery: A Comprehensive Review of Robotic Innovations in Breast Surgery and Reconstruction. Cureus. 2024 Jan 21;16(1):e52695. doi: 10.7759/cureus.52695. eCollection 2024 Jan.

  PMID: 38384645 BACKGROUND

• Toesca A, Peradze N, Manconi A, Galimberti V, Intra M, Colleoni M, Bonanni B, Curigliano G, Rietjens M, Viale G, Sacchini V, Veronesi P. Robotic nipple-sparing mastectomy for the treatment of breast cancer: Feasibility and safety study. Breast. 2017 Feb;31:51-56. doi: 10.1016/j.breast.2016.10.009. Epub 2016 Nov 2.

  PMID: 27810700 BACKGROUND

• Khan MF, Kearns E, Cahill RA. Clinical Experience of a Smart Articulating Digital Device for Transanal Minimally Invasive Surgery. Dis Colon Rectum. 2023 Dec 1;66(12):e1265-e1268. doi: 10.1097/DCR.0000000000002987. Epub 2023 Sep 25.

  PMID: 37787571 BACKGROUND

• Mao R, Gao L, Gang W, Wen L. Literature Review of Handheld Articulating Instruments in Minimally Invasive Surgery. J Laparoendosc Adv Surg Tech A. 2024 Jan;34(1):47-54. doi: 10.1089/lap.2023.0366. Epub 2023 Oct 23.

  PMID: 37870762 BACKGROUND

• Cao L, Shenk R, Miller ME, Towe C. Minimally Invasive Mastectomy Could Achieve Non-inferior Oncological Outcome in Appropriately Selected Patients: Propensity Matched Analysis of the National Cancer Database. Am Surg. 2022 Dec;88(12):2893-2898. doi: 10.1177/00031348211011152. Epub 2021 Apr 16.

  PMID: 33861667 BACKGROUND

• Mok CW, Lai HW. Evolution of minimal access breast surgery. Gland Surg. 2019 Dec;8(6):784-793. doi: 10.21037/gs.2019.11.16.

  PMID: 32042687 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Breast Cancer, Familial; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Vasileios Kalles, MD, MSc, PhD, FEBS

  Mediterraneo Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vasileios Kalles, MD, MSc, PhD, FEBS

CONTACT

00306973746477; vassilis_kalles@yahoo.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vasileios Kalles MD, MSc, PhD, FEBS, Consultant Breast & General Surgeon, Director of Mediterraneo Breast Clinic

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 18, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)