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Clinical Trials in the USA / NCT04447339
Active, not recruiting Observational

Open Nipple Sparing Mastectomy (NSM)

NCT04447339 · tracked via the Priya Life Science USA tracker
Sponsor
Intuitive Surgical
Phase
Observational
Started
2020-09-21
Last updated
2026-03-24

Condition(s) studied

Nipple Sparing Mastectomy

Investigational drug(s) / intervention(s)

Nipple Sparing Mastectomy

Nipple Sparing Mastectomy: Prophylactic open NSM procedures

Study summary

This is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
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: \-

Primary outcome measure(s)

  • Safety Endpoint: complication rate — IntraOperative period through 42 days postoperatively
    To assess the number of open prophylactic nipple sparing mastectomy complications compared to the number of procedures
  • Effectiveness — IntraOperative period through 42 days postoperatively
    Ability to completely excise memory gland tissue and preserve Nipple Areola Complex

Trial sites (5)

FacilityCityRegionStatus
NorthShore University Health System Evanston Illinois
Mayo Clinic Hosp - Methodist Campus - MN Rochester Minnesota
Northwell Health Queens New York
Pennsylvania Hospital Philadelphia Pennsylvania
Univ. of Texas MD Anderson Cancer Center Houston Texas

More Intuitive Surgical trials in the USA

Clinical Investigation of the da Vinci Surgical System Active, not recruiting
Real World Registry for Use of the Ion Endoluminal System Active, not recruiting
Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy Active, not recruiting
Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair Recruiting
da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures Active, not recruiting

Other trials for the same condition

Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04447339 on ClinicalTrials.gov ↗ ← All trials in the USA