Nipple Sparing Mastectomy Clinical Trial
— NSM OpenOfficial 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
Status | Recruiting |
Enrollment | 75 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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: - |
Country | Name | City | State |
---|---|---|---|
United States | NorthShore University Health System | Evanston | Illinois |
United States | Univ. of Texas MD Anderson Cancer Center | Houston | Texas |
United States | Pennsylvania Hospital | Philadelphia | Pennsylvania |
United States | Northwell Health | Queens | New York |
United States | Mayo Clinic Hosp - Methodist Campus - MN | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Intuitive Surgical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety Endpoint: complication rate | To assess the number of open prophylactic nipple sparing mastectomy complications compared to the number of procedures | IntraOperative period through 42 days postoperatively | |
Primary | Effectiveness | Ability to completely excise memory gland tissue and preserve Nipple Areola Complex | IntraOperative period through 42 days postoperatively |
Status | Clinical Trial | Phase | |
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