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Robotic arms take on breast cancer surgery: a new hope for nipple preservation?

NCT ID NCT05720039

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a robotic surgical system (da Vinci SP) to traditional open surgery for nipple-sparing mastectomy in women with early-stage breast cancer. The trial involves 204 participants and will measure safety, cancer recurrence, and patient satisfaction. The goal is to see if the robotic approach offers similar or better outcomes with potentially less scarring.

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 SP surgical system
What this could lead to
If successful, this could show that robotic nipple-sparing mastectomy is as safe and effective as open surgery, potentially offering a less invasive option for breast cancer patients.
What could go wrong
This is a relatively early-stage trial with 204 participants, so results may not apply to all patients. Robotic surgery may have higher costs or longer procedure times, and cancer recurrence rates will need long-term follow-up.

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 204 people

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

Started

May 2023

Expected to finish

Mar 2031

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

21 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 age 21 or older * BMI \< 30 * Candidate for an NSM procedure with immediate reconstruction * Diagnosis of early stage brest cancer * Breast ptosis ≤ Grade 2. * Cup size ≤ C. Exclusion Criteria: * Previous breast surgery * Diagnosis of metastatic breast cancer * Prior radiation treatment to the chest * Current smokers * Contraindication for general anesthesia or surgery. * Known bleeding or clotting disorder. * Pregnant or suspected to be pregnant, or actively breastfeeding

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Conditions

The condition(s) this trial relates to.

breast cancer breast disorder breast neoplasm female breast carcinoma

As listed by the trial registrant

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

BREAST Breast cancer Breast cancer female Breast cancer, early-onset Breast disease

Contacts and locations

Locations

  • Ascension St. Columbia Mary's

    Milwaukee, Wisconsin, 53211, United States

  • Cedars-Sinai

    Los Angeles, California, 940048, United States

  • City of Hope

    Irvine, California, 92618, United States

  • Corewell

    Detroit, Michigan, 48073, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Emory University

    Atlanta, Georgia, 30342, United States

  • Endeavor Health

    Evanston, Illinois, 60201, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55902, United States

  • Northwell Health

    Lake Success, New York, 11042, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19107, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Vanderbilt

    Nashville, Tennessee, 37232, United States

  • Washington University, St. Louis

    St Louis, Missouri, 63110, United States

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