NCT04447339

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Sep 2020Dec 2026

First Submitted

Initial submission to the registry

June 16, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 21, 2020

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

6.3 years

First QC Date

June 16, 2020

Last Update Submit

March 20, 2026

Conditions

Nipple Sparing Mastectomy

Outcome Measures

Primary Outcomes (2)

  • 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

  • Effectiveness

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

    IntraOperative period through 42 days postoperatively

Study Arms (1)

Open

Prophylactic NSM cases by Open approach

Procedure: Nipple Sparing Mastectomy

Interventions

Nipple Sparing MastectomyPROCEDURE

Prophylactic open NSM procedures

Open

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All female patients that have undergone open prophylactic NSM cases performed between January 1, 2018 through 42 days prior to IRB approval

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Mayo Clinic Hosp - Methodist Campus - MN

Rochester, Minnesota, 55905, United States

Location

Northwell Health

Queens, New York, 11040, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Univ. of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Mastectomy, Subcutaneous

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 25, 2020

Study Start

September 21, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

US(5)