Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04447339

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Nipple Sparing Mastectomy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

NorthShore University Health System, Evanston, Illinois, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Nipple sparing mastectomy

Procedure

Prophylactic open NSM procedures

Primary outcomes

  1. Safety Endpoint: complication rate

    Time frame: IntraOperative period through 42 days postoperatively

    To assess the number of open prophylactic nipple sparing mastectomy complications compared to the number of procedures

  2. Effectiveness

    Time frame: IntraOperative period through 42 days postoperatively

    Ability to completely excise memory gland tissue and preserve Nipple Areola Complex

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study title

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

Acronym: NSM Open

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2020
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.