Nipple Sparing MastectomyNCT03892980
Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy
A study testing Nipple-Sparing Mastectomy in people with Nipple Sparing Mastectomy, run by Intuitive Surgical at 6 sites in United States.
Trial summary
This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Nipple Sparing Mastectomy
- What is being tested?
- Nipple-Sparing Mastectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 6 sitesUnited States
- Study dates
- 26 Mar 2021to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
NorthShore University Health System
Evanston, Illinois, 60201
MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic Florida
Jacksonville, Florida, 32224
Northwell Health
New Hyde Park, New York, 11040
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Prospective, Multicenter Investigation of the da Vinci® Surgical Systems in Nipple Sparing Mastectomy (NSM) Procedures
This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.
Read the detailed description
Surgical management for breast cancer and risk-reducing techniques have evolved from radical mastectomy to other techniques such as nipple and skin sparing procedures. Nipple-sparing mastectomy (NSM) with reconstruction technology offers the opportunity to preserve the shape of both the breast and the nipple-areola complex.
This study will evaluate the safety and effectiveness of the da Vinci Surgical Systems in NSM procedures.
- Conditions
- Nipple Sparing Mastectomy
- Being tested
- Nipple-Sparing Mastectomy
- Keywords
- breast, robot, robotic, nipple sparing mastectomy, NSM, da Vinci, surgery, mastectomy, prophylactic NSM, risk reducing, BRCA mutation, nipple areola complex, NAC, RNSM, high-risk genetic mutation, gene mutation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nipple-Sparing MastectomyDevice
Nipple-sparing mastectomy using da Vinci Surgical Systems.
| Study group | Role | What they receive |
|---|---|---|
| Nipple Sparing Mastectomy | Experimental | Not described Receives: Device: Nipple-Sparing Mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness: No conversions to open NSM
Conversion is defined as conversion of da Vinci robotic-assisted surgery to open surgery
Measured: Assessed during surgery
Primary Safety: Incidence of adverse events
Incidence of intraoperative and post-operative procedure and device-related adverse events
Measured: Assessed during surgery to 42 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start26 Mar 2021
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nipple Sparing MastectomyStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci Surgical Systems
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892980
- Sponsor's protocol ID
- ISI dV Xi-SP NSM
- Status last verified
- Dec 2025
- First submitted
- 21 Mar 2019
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Investigation of the da Vinci® Surgical Systems in Nipple Sparing Mastectomy (NSM) Procedures
- ClinicalTrials.gov ID
- NCT03892980
- Acronym / sponsor ID
- ISI dV Xi-SP NSM
- Conditions
- Nipple Sparing Mastectomy
- Keywords
- breast, robot, robotic, nipple sparing mastectomy, NSM, da Vinci, surgery, mastectomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.
Detailed description
Surgical management for breast cancer and risk-reducing techniques have evolved from radical mastectomy to other techniques such as nipple and skin sparing procedures. Nipple-sparing mastectomy (NSM) with reconstruction technology offers the opportunity to preserve the shape of both the breast and the nipple-areola complex.
This study will evaluate the safety and effectiveness of the da Vinci Surgical Systems in NSM procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci Surgical Systems
| Arm | Type | Receives |
|---|---|---|
| Nipple Sparing Mastectomy | Experimental | Device: Nipple-Sparing Mastectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nipple-Sparing MastectomyNipple-sparing mastectomy using da Vinci Surgical Systems. | Device | Nipple Sparing Mastectomy |
Primary outcome
Primary Effectiveness: No conversions to open NSM
Time frame: Assessed during surgery
Conversion is defined as conversion of da Vinci robotic-assisted surgery to open surgery
Primary Safety: Incidence of adverse events
Time frame: Assessed during surgery to 42 days after surgery
Incidence of intraoperative and post-operative procedure and device-related adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nipple-Sparing Mastectomy in people with Nipple Sparing Mastectomy, run by Intuitive Surgical at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness: No conversions to open NSM (time frame: Assessed during surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.