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Open Nipple Sparing Mastectomy (NSM)

A Retrospective, Multicenter Study of Open Nipple Sparing Mastectomy (NSM)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04447339
Acronym
NSM Open
Enrollment
75
Registered
2020-06-25
Start date
2020-09-21
Completion date
2026-12-31
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nipple Sparing Mastectomy

Brief summary

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

Interventions

Prophylactic open NSM procedures

Sponsors

Intuitive Surgical
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All female patients that have undergone open prophylactic NSM cases performed between January 1, 2018 through 42 days prior to IRB approval

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Safety Endpoint: complication rateIntraOperative period through 42 days postoperativelyTo assess the number of open prophylactic nipple sparing mastectomy complications compared to the number of procedures
EffectivenessIntraOperative period through 42 days postoperativelyAbility to completely excise memory gland tissue and preserve Nipple Areola Complex

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026