Open Nipple Sparing Mastectomy (NSM)

Nipple Sparing Mastectomy Clinical Trial

— NSM Open  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04447339
• Other study ID #: ISI-RoNSM-01
• Status: Recruiting
• Start date: September 21, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Intuitive Surgical
• Contact: Tish Mikoczi
• Phone: 760-274-5811
• Email: tish.mikoczi[@]intusurg.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• 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: -

Related Conditions & MeSH terms

• Nipple Sparing Mastectomy

Intervention

Procedure:
• Nipple Sparing Mastectomy
Prophylactic open NSM procedures

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

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