Nipple Sparing MastectomyNSM OpenNCT04447339
Open Nipple Sparing Mastectomy (NSM)
An observational study of Nipple Sparing Mastectomy, run by Intuitive Surgical at 5 sites in United States.
Trial summary
This is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Nipple Sparing Mastectomy
- What is being tested?
- Nipple Sparing Mastectomy
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 5 sitesUnited States
- Study dates
- 21 Sep 2020to 31 Dec 2026
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive subjects that have undergone open NSM procedures for prophylaxis between January 1 2018 through 42 days prior to IRB approval will be included in this retrospective chart review.
Who may be able to join
- All female patients that have undergone open prophylactic NSM cases performed between January 1, 2018 through 42 days prior to IRB approval
Who cannot join
- -
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
NorthShore University Health System
Evanston, Illinois, 60201
Univ. of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Northwell Health
Queens, New York, 11040
Mayo Clinic Hosp - Methodist Campus - MN
Rochester, Minnesota, 55905
About this study
Official title: A Retrospective, Multicenter Study of Open Nipple Sparing Mastectomy (NSM)
This is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively
Read the detailed description
This is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively
- Conditions
- Nipple Sparing Mastectomy
- Being tested
- Nipple Sparing Mastectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nipple Sparing MastectomyProcedure or surgery
Prophylactic open NSM procedures
| Study group | Role | What they receive |
|---|---|---|
| Open | Prophylactic NSM cases by Open approach Receives: Procedure: Nipple Sparing Mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint: complication rate
To assess the number of open prophylactic nipple sparing mastectomy complications compared to the number of procedures
Measured: IntraOperative period through 42 days postoperatively
Effectiveness
Ability to completely excise memory gland tissue and preserve Nipple Areola Complex
Measured: IntraOperative period through 42 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start21 Sep 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 75 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
- NCT04447339
- Sponsor's protocol ID
- ISI-RoNSM-01
- Acronym
- NSM Open
- Status last verified
- Mar 2026
- First submitted
- 16 Jun 2020
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Multicenter Study of Open Nipple Sparing Mastectomy (NSM)
- ClinicalTrials.gov ID
- NCT04447339
- Acronym / sponsor ID
- NSM Open / ISI-RoNSM-01
- Conditions
- Nipple Sparing Mastectomy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jun 2020 (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 is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively
Detailed description
This is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open | – | Procedure: Nipple Sparing MastectomyProphylactic NSM cases by Open approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive subjects that have undergone open NSM procedures for prophylaxis between January 1 2018 through 42 days prior to IRB approval will be included in this retrospective chart review.
Key inclusion criteria (1 listed)
- All female patients that have undergone open prophylactic NSM cases performed between January 1, 2018 through 42 days prior to IRB approval
Key exclusion criteria (1 listed)
- -
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 MastectomyProphylactic open NSM procedures | Procedure or surgery | Open |
Primary outcome
Safety Endpoint: complication rate
Time frame: IntraOperative period through 42 days postoperatively
To assess the number of open prophylactic nipple sparing mastectomy complications compared to the number of procedures
Effectiveness
Time frame: IntraOperative period through 42 days postoperatively
Ability to completely excise memory gland tissue and preserve Nipple Areola Complex
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 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nipple Sparing Mastectomy, run by Intuitive Surgical at 5 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 1 inclusion and 1 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 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Safety Endpoint: complication rate (time frame: IntraOperative period through 42 days postoperatively). 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 24 Mar 2026.