Open Nipple Sparing Mastectomy (NSM)

NCT ID: NCT04447339

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-21

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Nipple Sparing Mastectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Open

Prophylactic NSM cases by Open approach

Nipple Sparing Mastectomy

Intervention Type PROCEDURE

Prophylactic open NSM procedures

Interventions

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Nipple Sparing Mastectomy

Prophylactic open NSM procedures

Intervention Type PROCEDURE

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Intuitive Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NorthShore University Health System

Evanston, Illinois, United States

Site Status RECRUITING

Mayo Clinic Hosp - Methodist Campus - MN

Rochester, Minnesota, United States

Site Status RECRUITING

Northwell Health

Queens, New York, United States

Site Status RECRUITING

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Univ. of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tish Mikoczi

Role: CONTACT

Phone: 760-274-5811

Email: [email protected]

Cheryl Baclit

Role: CONTACT

Facility Contacts

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Katherine Kopkash, MD

Role: primary

Mayo CH-MC- MN

Role: primary

Alan Kadison, MD

Role: primary

Ari Brooks

Role: primary

Rosa F Hwang, MD, FACS

Role: primary

Other Identifiers

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ISI-RoNSM-01

Identifier Type: -

Identifier Source: org_study_id