An interventional study of Endoscopic nipple sparing mastectomy and HandX endoscopic instrument in Breast Cancer, BRCA 1 Gene Mutation and BRCA 2 Gene Mutation, sponsored by Vasileios Kalles. Recruiting at 1 site in Greece. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Vasileios Kalles · Not applicable, Interventional, and Treatment
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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.
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.
286 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 55 are open to participants now.
This study's planned enrollment of 15 is below the median of 66 across 208 interventional studies indexed under Carcinoma, Intraductal, Noninfiltrating.
Browse Carcinoma, Intraductal, Noninfiltrating studies →This is the only study on the registry with Vasileios Kalles as lead sponsor.
Compared within Carcinoma, Intraductal, Noninfiltrating, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Breast Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Indication for therapeutic or prophylactic (risk-reducing) mastectomy for:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient cohort undergoing endoscopic nipple sparing mastectomy with use of HandX.
Procedure: Endoscopic nipple sparing mastectomy · Device: HandX endoscopic instrument
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.
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.
Technical success
Completion of the planned procedure via the minimally invasive approach without unplanned conversion.
Time frame: Intraoperative (Day 0)
Surgical Safety
Major (Clavien-Dindo ≥III) complications
Time frame: Postoperative Day 0-30
Operative Time
Total Operative Time
Time frame: Intraoperative (Day 0)
Blood Loss
Intraoperative Blood Loss
Time frame: Intraoperative (Day 0)
Length of Stay
Length of hospital stay in days
Time frame: From hospitalization to discharge (average 1-3 days)
Complications
30-day complication rate (Clavien-Dindo)
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: Within 90 days after surgery
Implant loss
Need to remove the implant for any reason
Time frame: 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
Time frame: 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.
Time frame: Preoperatively up to 4 weeks, 1 month postoperatively, 6 months postoperatively, 12 months postoperatively
Plan to share: 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.
Started Sep 2025 (actual). Primary completion is estimated for Oct 2028, 37 months after the start.
Of 44 non-industry interventional studies with no phase under Carcinoma, Intraductal, Noninfiltrating, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 148. This study's planned 37 months is below that.
Counting every sponsor, half of 47 studies reached it within 69 months; a quarter within 30 and three quarters within 134.
How these figures are worked out, and which studies are left out of them.
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