Open Nipple Sparing Mastectomy (NSM) (NSM Open)

December 17, 2023 updated by: Intuitive Surgical

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Cheryl Baclit

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • NorthShore University Health System
        • Contact:
          • Katherine Kopkash, MD
        • Principal Investigator:
          • Katherine Kopkash, MD, FACS
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Hosp - Methodist Campus - MN
        • Contact:
          • Mayo CH-MC- MN
        • Principal Investigator:
          • James W Jacob, MD
    • New York
      • Queens, New York, United States, 11040
        • Recruiting
        • Northwell Health
        • Contact:
          • Alan Kadison, MD
        • Principal Investigator:
          • Alan Kadison, MD, FACS
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Pennsylvania Hospital
        • Contact:
          • Ari Brooks
        • Principal Investigator:
          • Ari Brooks, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Univ. of Texas MD Anderson Cancer Center
        • Contact:
          • Rosa F Hwang, MD, FACS
        • Principal Investigator:
          • Rosa F Hwang, MD, FACS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive subjects that have undergone open NSM procedures for prophylaxis between January 1 2018 through 42 days prior to IRB approval will be included in this retrospective chart review.

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Open
Prophylactic NSM cases by Open approach
Procedure: Nipple Sparing Mastectomy
Prophylactic open NSM procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
IntraOperative period through 42 days postoperatively
Effectiveness
Time Frame: IntraOperative period through 42 days postoperatively
Ability to completely excise memory gland tissue and preserve Nipple Areola Complex
IntraOperative period through 42 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intuitive Surgical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (Actual)

June 25, 2020

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 17, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ISI-RoNSM-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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