Active — Not RecruitingNot Applicable

Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy

United States145 participantsStarted 2021-03-26

Plain-language summary

This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.

Who can participate

Age range

18 Years – 80 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Effectiveness: No conversions to open NSM

Timeframe: Assessed during surgery

Primary Safety: Incidence of adverse events

Timeframe: Assessed during surgery to 42 days after surgery

Trial details

NCT IDNCT03892980

SponsorIntuitive Surgical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-30

View on ClinicalTrials.gov More Nipple Sparing Mastectomy trials