Breast Cancer FemaleSP NSMNCT05720039
Robotic vs. Open NSM for Early Stage Breast Cancer
A study testing Robotic NSM and Open NSM in people with Breast Cancer Female and Breast Cancer, run by Intuitive Surgical at 15 sites in United States.
Trial summary
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Breast Cancer, Breast Cancer, Early-Onset
- What is being tested?
- Robotic NSM and Open NSM
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 15 sitesUnited States
- Study dates
- 8 May 2023to Mar 2031
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Emory University
Atlanta, Georgia, 30342
Corewell
Detroit, Michigan, 48073
Duke University
Durham, North Carolina, 27710
Endeavor Health
Evanston, Illinois, 60201
MD Anderson Cancer Center
Houston, Texas, 77030
City of Hope
Irvine, California, 92618
Mayo Clinic Florida
Jacksonville, Florida, 32224
Northwell Health
Lake Success, New York, 11042
Cedars-Sinai
Los Angeles, California, 940048
Ascension St. Columbia Mary's
Milwaukee, Wisconsin, 53211
Vanderbilt
Nashville, Tennessee, 37232
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
Mayo Clinic Rochester
Rochester, Minnesota, 55902
University of Washington
Seattle, Washington, 98195
Washington University, St. Louis
St Louis, Missouri, 63110
About this study
Official title: A Prospective, Multicenter Randomized Controlled Trial(RCT) of the da Vinci® SP™ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
Read the detailed description
This study is a prospective, two-arm, multi-center, randomized controlled clinical investigation between RSNM and open NSM.
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
- Being tested
- Robotic NSM, Open NSM
- Keywords
- robotic, NSM, Nipple sparing mastectomy, da Vinci, breast cancer, mastectomy, breast, USA, robot, SP System, Single-port
- Medical subject headings
- Breast Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic NSMDevice
Also called RNSM, SP NSM
Robotic-assisted Nipple sparing mastectomy procedures
Open NSMProcedure or surgery
open nipple-sparing mastectomy procedures
| Study group | Role | What they receive |
|---|---|---|
| Robotic NSM with da Vinci SP | Experimental | Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures Receives: Device: Robotic NSM |
| Open NSM | Active comparator | Subjects randomized to this arm will undergo conventional open NSM procedures Receives: Procedure: Open NSM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion rate
Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery
Measured: Assessed during procedure
Safety: Adverse event rates
Incidence of intraoperative and post-operative procedure and device-related adverse events compared to open NSM
Measured: Up to 42 days post-operatively
Safety: positive surgical margin rates
Incidence of positive surgical margins compared to open NSM
Measured: Up to 42 days post-operatively
Secondary outcomes (6)
Oncological Outcomes (for cancer recurrence)
Recurrence
Measured: Up to 5 years
Oncological Outcomes (for disease-free survival)
Disease-free survival
Measured: Up to 5 years
Oncological Outcomes (for overall survival)
Overall survival
Measured: Up to 5 years
Patient-Report Outcomes (BREAST-Q)
BREAST-Q
Measured: Up to 5 years
Patient-Report Outcomes (NAC Questionnaire)
NAC Questionnaire
Measured: Up to 5 years
Patient-Report Outcomes (EQ-5D)
EQ-5D
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start8 May 2023
- Primary completionMar 2026 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci SP Surgical System or open NSM
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Madhu Gorrepati, Study director, Intuitive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720039
- Sponsor's protocol ID
- ISI dV SP - NSM-01
- Acronym
- SP NSM
- Status last verified
- Feb 2026
- First submitted
- 17 Jan 2023
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Randomized Controlled Trial(RCT) of the da Vinci® SP™ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures
- ClinicalTrials.gov ID
- NCT05720039
- Acronym / sponsor ID
- SP NSM / ISI dV SP - NSM-01
- Keywords
- robotic, NSM, Nipple sparing mastectomy, da Vinci, breast cancer, mastectomy, breast, USA
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 8 May 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 9 Feb 2023 (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 SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
Detailed description
This study is a prospective, two-arm, multi-center, randomized controlled clinical investigation between RSNM and open NSM.
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci SP Surgical System or open NSM
| Arm | Type | Receives |
|---|---|---|
| Robotic NSM with da Vinci SP | Experimental | Device: Robotic NSMSubjects randomized to this arm will undergo robotic NSM (RNSM) procedures |
| Open NSM | Active comparator | Procedure: Open NSMSubjects randomized to this arm will undergo conventional open NSM procedures |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- Previous breast surgery
- Diagnosis of metastatic breast cancer
- Prior radiation treatment to the chest
- Current smokers
- Contraindication for general anesthesia or surgery.
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 |
|---|---|---|
| Robotic NSMAlso: RNSM, SP NSMRobotic-assisted Nipple sparing mastectomy procedures | Device | Robotic NSM with da Vinci SP |
| Open NSMopen nipple-sparing mastectomy procedures | Procedure or surgery | Open NSM |
Primary outcome
Conversion rate
Time frame: Assessed during procedure
Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery
Safety: Adverse event rates
Time frame: Up to 42 days post-operatively
Incidence of intraoperative and post-operative procedure and device-related adverse events compared to open NSM
Safety: positive surgical margin rates
Time frame: Up to 42 days post-operatively
Incidence of positive surgical margins compared to open NSM
6 secondary outcomes
Oncological Outcomes (for cancer recurrence)
Time frame: Up to 5 years
Oncological Outcomes (for disease-free survival)
Time frame: Up to 5 years
Oncological Outcomes (for overall survival)
Time frame: Up to 5 years
Patient-Report Outcomes (BREAST-Q)
Time frame: Up to 5 years
Patient-Report Outcomes (NAC Questionnaire)
Time frame: Up to 5 years
Patient-Report Outcomes (EQ-5D)
Time frame: Up to 1 year
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 24 Feb 2026.
- 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.
Madhu Gorrepati study director
Intuitive
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic NSM and Open NSM in people with Breast Cancer Female and Breast Cancer, run by Intuitive Surgical at 15 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 6 inclusion and 7 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 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Conversion rate (time frame: Assessed during procedure). The study lists 3 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 24 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.