Breast CancerATHENA INCT07292246
A Prospective CohorT Study of HandX - Assisted ENdoscopic MAstectomy: Feasibility and Safety (ATHENA I Study)
A study testing Endoscopic nipple sparing mastectomy and HandX endoscopic instrument in people with Breast Cancer and BRCA 1 Gene Mutation, run by Vasileios Kalles at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
- What is being tested?
- Endoscopic nipple sparing mastectomy and HandX endoscopic instrument
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGreece
- Study dates
- 9 Sep 2025to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Mediterraneo Hospital
Glyfada, Attica, 16675
Vasileios Kalles, MD, MSc, PhD, FEBS, 00306973746477, vassilis_kalles@yahoo.gr
Ioannis Papapanagiotou, MD, MSc, PhD
About this study
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.
Read more
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.
Read the detailed description
This is a prospective, single-center, single-arm interventional study designed to evaluate the feasibility and surgical safety of HandX-assisted endoscopic nipple-sparing mastectomy with immediate implant-based breast reconstruction. The HandX system is a handheld articulating robotic instrument that provides wrist-like motion, motion scaling, and ergonomic control. Unlike console-based robotic platforms, HandX integrates into standard minimally invasive workflows without the need for a large footprint, dedicated console, or complex docking procedures. Early clinical experience in other surgical specialties suggests that the technology may improve access and ergonomics during dissection while maintaining procedural efficiency. This study investigates its use specifically in endoscopic breast surgery, where instrument articulation and visualization are key technical challenges.
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
- Breast Cancer, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation, Hereditary Breast Carcinoma, Breast Neoplasms, DCIS
- Being tested
- Endoscopic nipple sparing mastectomy, HandX endoscopic instrument
- Keywords
- breast cancer, mastectomy, endoscopic, robotic, handx, nipple-sparing mastectomy
- Medical subject headings
- Breast Neoplasms, Breast Cancer, Familial, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic nipple sparing mastectomyProcedure or surgery
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 instrumentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HandX-assisted endoscopic nipple sparing mastectomy | Experimental | Patient cohort undergoing endoscopic nipple sparing mastectomy with use of HandX. Receives: Procedure: Endoscopic nipple sparing mastectomy; Device: HandX endoscopic instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Completion of the planned procedure via the minimally invasive approach without unplanned conversion.
Measured: Intraoperative (Day 0)
Surgical Safety
Major (Clavien-Dindo ≥III) complications
Measured: Postoperative Day 0-30
Secondary outcomes (10)
Operative Time
Total Operative Time
Measured: Intraoperative (Day 0)
Blood Loss
Intraoperative Blood Loss
Measured: Intraoperative (Day 0)
Length of Stay
Length of hospital stay in days
Measured: From hospitalization to discharge (average 1-3 days)
Complications
30-day complication rate (Clavien-Dindo)
Measured: Within 30 days after surgery
Skin flap necrosis
The presence of skin flap necrosis will be noted during all the visits after the surgery (POD 7, 14, 28).
Measured: Within 30 days after surgery
Nipple Areola Complex ischemia
Nipple-Areola-Complex (NAC) Ischemia noted during all the visits after the surgery (POD 7, 14, 28)
Measured: Within 30 days after surgery
Surgical Site Infection
Number of participants with SSI (CDC/NHSN). Superficial incisional primary (SIP) within 30 days; deep incisional primary (DIP) and organ/space (O/S) within 90 days after the index BRST procedure.
Measured: Within 90 days after surgery
Implant loss
Need to remove the implant for any reason
Measured: Within 1 year after surgery
Short - term Oncologic Adequacy
Negative surgical margins on final pathology-retroareolar (nipple) margin negative and no tumor on ink on any sampled skin-flap or deep margin
Measured: Within 40 days after surgery
PROMs - Aesthetic Outcome
BREAST-Q© questionnaire Version 2.0 measure the quality of life and satisfaction among patients undergoing breast surgery - Reconstruction module pre and postoperative, higher scores reflect a better outcome.
Measured: Preoperatively up to 4 weeks, 1 month postoperatively, 6 months postoperatively, 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start9 Sep 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vasileios Kalles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vasileios Kalles, Mediterraneo Hospital
- Investigators
- Vasileios Kalles, MD, MSc, PhD, FEBS, Principal investigator, Mediterraneo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292246
- Sponsor's protocol ID
- 516
- Acronym
- ATHENA I
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "Individual participant data (IPD) will not be shared. This study is a small single-center feasibility trial, and the dataset contains clinical and surgical details that cannot be fully de-identified under GDPR. Summary results will be made available in the ClinicalTrials.gov record after study completion.
Publications
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.
PubMed 28692558Jain 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.
PubMed 38384645Toesca 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.
PubMed 27810700Khan 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.
PubMed 37787571Mao 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.
PubMed 37870762Cao 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.
PubMed 33861667Mok CW, Lai HW. Evolution of minimal access breast surgery. Gland Surg. 2019 Dec;8(6):784-793. doi: 10.21037/gs.2019.11.16.
PubMed 32042687
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective CohorT Study of HandX - Assisted ENdoscopic MAstectomy: Feasibility and Safety (ATHENA I Study)
- ClinicalTrials.gov ID
- NCT07292246
- Acronym / sponsor ID
- ATHENA I / 516
- Conditions
- Breast Cancer, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation, Hereditary Breast Carcinoma, Breast Neoplasms, DCIS
- Keywords
- breast cancer, mastectomy, endoscopic, robotic, handx, nipple-sparing mastectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Vasileios KallesUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single-center, single-arm interventional study designed to evaluate the feasibility and surgical safety of HandX-assisted endoscopic nipple-sparing mastectomy with immediate implant-based breast reconstruction. The HandX system is a handheld articulating robotic instrument that provides wrist-like motion, motion scaling, and ergonomic control. Unlike console-based robotic platforms, HandX integrates into standard minimally invasive workflows without the need for a large footprint, dedicated console, or complex docking procedures. Early clinical experience in other surgical specialties suggests that the technology may improve access and ergonomics during dissection while maintaining procedural efficiency. This study investigates its use specifically in endoscopic breast surgery, where instrument articulation and visualization are key technical challenges.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HandX-assisted endoscopic nipple sparing mastectomy | Experimental | Procedure: Endoscopic nipple sparing mastectomy, Device: HandX endoscopic instrumentPatient cohort undergoing endoscopic nipple sparing mastectomy with use of HandX. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female sex
- Age ≥ 18 years old
- Indication for therapeutic or prophylactic (risk-reducing) mastectomy for:
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic nipple sparing mastectomyA 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. | Procedure or surgery | HandX-assisted endoscopic nipple sparing mastectomy |
| HandX endoscopic instrumentA 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. | Device | HandX-assisted endoscopic nipple sparing mastectomy |
Primary outcome
Technical success
Time frame: Intraoperative (Day 0)
Completion of the planned procedure via the minimally invasive approach without unplanned conversion.
Surgical Safety
Time frame: Postoperative Day 0-30
Major (Clavien-Dindo ≥III) complications
10 secondary outcomes
Operative Time
Time frame: Intraoperative (Day 0)
Blood Loss
Time frame: Intraoperative (Day 0)
Length of Stay
Time frame: From hospitalization to discharge (average 1-3 days)
Complications
Time frame: Within 30 days after surgery
Skin flap necrosis
Time frame: Within 30 days after surgery
Nipple Areola Complex ischemia
Time frame: Within 30 days after surgery
Surgical Site Infection
Time frame: Within 90 days after surgery
Implant loss
Time frame: Within 1 year after surgery
Short - term Oncologic Adequacy
Time frame: Within 40 days after surgery
PROMs - Aesthetic Outcome
Time frame: Preoperatively up to 4 weeks, 1 month postoperatively, 6 months postoperatively, 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Background: PubMed 28692558Toesca 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.
- Background: PubMed 38384645Jain 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.
- Background: PubMed 27810700Toesca 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.
- Background: PubMed 37787571Khan 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.
- Background: PubMed 37870762Mao 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.
- Background: PubMed 33861667Cao 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.
- Background: PubMed 32042687Mok CW, Lai HW. Evolution of minimal access breast surgery. Gland Surg. 2019 Dec;8(6):784-793. doi: 10.21037/gs.2019.11.16.
- Individual participant dataSharing planned: No. "Individual participant data (IPD) will not be shared. This study is a small single-center feasibility trial, and the dataset contains clinical and surgical details that cannot be fully de-identified under GDPR. Summary results will be made available in the ClinicalTrials.gov record after study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vasileios Kalles, MD, MSc, PhD, FEBS principal investigator
Mediterraneo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic nipple sparing mastectomy and HandX endoscopic instrument in people with Breast Cancer and BRCA 1 Gene Mutation, run by Vasileios Kalles at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vasileios Kalles, MD, MSc, PhD, FEBS (00306973746477, vassilis_kalles@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: Intraoperative (Day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07292246, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.