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Robot-Assisted breast surgery: a new hope for High-Risk women?

NCT ID NCT03892980

Disease control Sponsor: Intuitive Surgical 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether the da Vinci surgical robot can safely and effectively perform nipple-sparing mastectomy in 145 women at high risk for breast cancer. The goal is to see if the robot can avoid the need to switch to open surgery and to track any side effects. If it works, it could offer a less invasive option for preventive breast removal.

What this could mean

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

Active substance
da Vinci Surgical System (robot-assisted surgery device)
What this could lead to
If successful, this could show that robot-assisted nipple-sparing mastectomy is a safe and effective option for women at high risk of breast cancer, potentially reducing complications and improving cosmetic outcomes.
What could go wrong
This is an early-stage study with only 145 participants, so results may not apply to all women. There is a risk of surgical complications or the need to convert to open surgery during the procedure.

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 145 people

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

Started

Mar 2021

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 80 years

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 between ages 18-80. * BMI ≤ 29. * Candidate for an NSM procedure. * At increased risk for breast cancer and is seeking prophylactic NSM surgery or subject has breast cancer in one breast and is seeking prophylactic NSM on contralateral side. * Breast ptosis ≤ Grade 2. * Cup size ≤ C. * No presence of occult cancer on the side for which she is seeking prophylactic NSM surgery as confirmed by physical exam and by preoperative imaging per institution's guidelines. Exclusion Criteria: * Current or prior history of ipsilateral in-situ or invasive breast carcinoma on the breast for which she is seeking prophylactic NSM surgery. * Previous breast surgery of the ipsilateral breast (excluding needle or core biopsies and excisional biopsies performed more than 1 year prior). * Current history of smoking or has smoked within 1 year of screening. * Skin conditions * Uncontrolled diabetes mellitus. * Previous chemotherapy or radiation * High risk for anesthesia or significant medical comorbidities * Contraindicated for general anesthesia or surgery. * Known bleeding or clotting disorder. * Pregnant or suspected to be pregnant or is lactating.

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Conditions

The condition(s) this trial relates to.

breast cancer prevention target

As listed by the trial registrant

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

Nipple sparing mastectomy

Contacts and locations

Locations

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • NorthShore University Health System

    Evanston, Illinois, 60201, United States

  • Northwell Health

    New Hyde Park, New York, 11040, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19107, United States

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