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Robot surgeons take on breast cancer: will they beat the scalpel?

NCT ID NCT07230535

Symptom relief Sponsor: Beaumont Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two ways to perform nipple-sparing mastectomy with immediate DIEP flap breast reconstruction: robotic-assisted surgery through a single small incision, versus the standard open surgery with a larger cut. The goal is to see which approach leads to better patient satisfaction, body image, and overall well-being one year after surgery. About 250 women with early breast cancer or high genetic risk will take part across multiple hospitals in Ireland.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Robotic-assisted nipple-sparing mastectomy procedure
What this could lead to
If robotic surgery proves better, it could offer women less scarring, less pain, and higher satisfaction after mastectomy with reconstruction.
What could go wrong
This is a relatively early randomized trial; robotic surgery may not improve outcomes enough to justify its cost and complexity. Risks include surgical complications and limited generalizability.

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 250 people

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

Started

Dec 2025

Expected to finish

Dec 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: * Women aged 18 years and older * Candidates who have already been selected to undergo mastectomy (of any kind) and immediate DIEP reconstruction by the breast MDT for the following indications: 1. Genetic mutation carriers undergoing risk-reducing mastectomy. 2. Ductal carcinoma in situ (DCIS) requiring mastectomy. 3. Early invasive breast cancer requiring mastectomy. 4. For those considered for Nipple Sparing Mastectomy randomisation arms the tumour must not have skin involvement and no evidence of invasive disease within 1cm of skin, nipple or Pec major muscle (as proven on MRI). * Candidates for immediate breast reconstruction with DIEP reconstruction * Fluent in English * Fit for general anaesthetic * Signed informed consent form Exclusion Criteria: * Advanced breast cancer with skin involvement for Nipple Sparing Mastectomy Arms * Nipple involvement for Nipple Sparing Mastectomy Arms. * Prior chest wall radiation therapy * Pregnancy * Lactation * Patients with insufficient English to sign an informed consent (i.e. interpreter required).

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Conditions

The condition(s) this trial relates to.

breast neoplasm ductal breast carcinoma in situ invasive breast carcinoma breast cancer prevention target

As listed by the trial registrant

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

Breast cancer, breast neoplasms Breast reconstruction Diep flap breast reconstruction Robotic surgery

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

  • Beaumont RCSI Cancer Centre

    RECRUITING

    Beaumont, D09, Ireland

More trials for these conditions

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