Open Nipple Sparing Mastectomy (NSM)
- Conditions
- Nipple Sparing Mastectomy
- Interventions
- Procedure: Nipple Sparing Mastectomy
- Registration Number
- NCT04447339
- Lead Sponsor
- Intuitive Surgical
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 75
All female patients that have undergone open prophylactic NSM cases performed between January 1, 2018 through 42 days prior to IRB approval
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Open Nipple Sparing Mastectomy Prophylactic NSM cases by Open approach
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
NorthShore University Health System
🇺🇸Evanston, Illinois, United States
Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Univ. of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Northwell Health
🇺🇸Queens, New York, United States
Mayo Clinic Hosp - Methodist Campus - MN
🇺🇸Rochester, Minnesota, United States