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Robot-Assisted mastectomy: could it mean less pain and faster healing?

NCT ID NCT07236359

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 trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares two types of nipple-sparing mastectomy: one done with a robotic arm through a small side incision, and the standard open surgery. Researchers want to see if the robotic method improves women's satisfaction, body image, and recovery over 12 months. The trial will include 108 women who are already scheduled for mastectomy and immediate implant reconstruction.

What this could mean

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

Active substance
Robotic single-port nipple-sparing mastectomy with immediate implant reconstruction
What this could lead to
If this works, it could show that robotic surgery leads to less scarring, less pain, and faster recovery for women needing mastectomy and reconstruction.
What could go wrong
This is a small, early-stage trial (108 participants) that hasn't started yet. Robotic surgery may not prove significantly better than standard open surgery, and results may not apply to all patients.

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 108 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2028

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 nipple sparing mastectomy and immediate implant reconstruction by the breast MDT for the following indications: * Genetic mutation carriers undergoing risk-reducing mastectomy. * Ductal carcinoma in situ (DCIS) requiring mastectomy. * Early invasive breast cancer requiring mastectomy. * 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 IMPLANT reconstruction * Fluent in English * Fit for general anaesthetic * Signed informed consent form Exclusion Criteria: * Advanced breast cancer with skin involvement. * 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 cancer breast neoplasm ductal breast carcinoma in situ hereditary breast ovarian cancer syndrome

As listed by the trial registrant

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

Breast cancer Breast reconstruction Hereditary breast/ovarian cancer (BRCA1, BRCA2) Robotic surgery

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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