A Prospective CohorT Study of HandX - Assisted ENdoscopic MAstectomy: Feasibility and Safety (ATHENA I Study)
NCT ID: NCT07292246
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2025-09-09
2029-10-31
Brief Summary
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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.
Detailed Description
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All participants will undergo the mastectomy through a single lateral mammary fold incision. Following tumescent injection and creation of a working space, a single-port device is placed, and CO₂ insufflation is used to establish the operative cavity. The HandX device is then employed for endoscopic dissection of the breast gland from the skin envelope and the nipple-areola complex. Specimen retrieval is performed through the same incision. Reconstruction is completed using implant-based techniques (prepectoral, dual-plane, PU-coated, or subpectoral), according to preoperative planning and standard practice. Axillary procedures (sentinel lymph node biopsy or axillary lymph node dissection) may be performed through the same incision when indicated.
The study focuses on technical feasibility-specifically, the ability to complete the endoscopic mastectomy using the HandX platform without unplanned conversion to an open approach. Technical success is defined in the protocol and includes completion of all key steps of the planned minimally invasive procedure. Adjunct use of standard laparoscopic instruments or minor incision extensions for specimen handling does not constitute conversion, provided that the minimally invasive workflow is preserved.
Safety outcomes include intraoperative complications, 30-day and 90-day postoperative adverse events, surgical site infections assessed according to CDC/NHSN definitions, implant-related complications, and implant loss through one year. Postoperative care follows standardized pathways for implant-based reconstruction, including consistent antibiotic and VTE prophylaxis policies and predefined criteria for drain management. Participants are reviewed at scheduled visits through postoperative day 28, with additional follow-up through day 90 for infection surveillance, and through one year for implant-related outcomes.
Patient-reported outcomes are assessed using the BREAST-Q® Reconstruction Module (Version 2.0), administered preoperatively and at postoperative months 1, 6, and 12. These measures provide data on satisfaction with breasts, psychosocial and sexual well-being, physical well-being of the chest, and satisfaction with aspects of care. Only implant-reconstruction-relevant scales are used.
All data are collected in electronic case report forms, stored securely, and managed in compliance with GDPR and institutional policies. Monitoring is internal due to the single-center pilot nature of the study.
The study plans to accrue up to 20 mastectomy cases, corresponding to approximately 15 participants, as bilateral procedures are counted per breast. The sample size of 20 cases is consistent with recommendations for feasibility studies intended to inform future multicenter comparative trials. Analyses are descriptive. Technical success, complication rates, and patient-reported outcomes will be summarized with confidence intervals. Progression criteria and stopping rules are predefined in the protocol, including thresholds for major complications, device-related serious events, and oncologic or surgical concerns that may warrant pause or termination of the study.
Findings from this pilot study will inform the development of larger controlled trials evaluating the comparative effectiveness, aesthetic outcomes, recovery profiles, and cost implications of HandX-assisted endoscopic mastectomy relative to other surgical approaches.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HandX-assisted endoscopic nipple sparing mastectomy
Patient cohort undergoing endoscopic nipple sparing mastectomy with use of HandX.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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) undergoing surgery post systemic (neoadjuvant) therapy with clinical evidence of partial or complete response
3. ductal carcinoma in situ (DCIS), or
4. BRCA or other breast cancer - related genetic mutation carriers, or
5. 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Vasileios Kalles
OTHER
Responsible Party
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Vasileios Kalles
Vasileios Kalles MD, MSc, PhD, FEBS, Consultant Breast & General Surgeon, Director of Mediterraneo Breast Clinic
Principal Investigators
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Vasileios Kalles, MD, MSc, PhD, FEBS
Role: PRINCIPAL_INVESTIGATOR
Mediterraneo Hospital
Locations
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Mediterraneo Hospital
Glyfada, Attica, Greece
Countries
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Central Contacts
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Facility Contacts
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Vasileios Kalles, MD, MSc, PhD, FEBS
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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516
Identifier Type: -
Identifier Source: org_study_id