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Robot-Assisted mastectomy: smaller scars, same safety?

NCT ID NCT07292246

Disease control Sponsor: Vasileios Kalles Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a handheld robotic tool called HandX to help surgeons perform a nipple-sparing mastectomy through a single small incision. The goal is to remove breast tissue while keeping the skin and nipple, leading to less scarring and better cosmetic results. About 15 women who already need a mastectomy for breast cancer or genetic risk will take part. Researchers will track surgery success, complications, and patient satisfaction for up to a year.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female sex * 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: * 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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm ductal breast carcinoma in situ hereditary breast carcinoma invasive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BRCA 1 gene mutation BRCA 2 gene mutation Breast cancer Breast neoplasms DCIS Early breast cancer Germline mutation abnormality Hereditary breast carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mediterraneo Hospital

    RECRUITING

    Glyfada, Attica, 16675, Greece

More trials for these conditions

Other studies related to the condition(s) this trial covers.