Status:

COMPLETED

Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy (SPrNSM)

Lead Sponsor:

University of Texas Southwestern Medical Center

Conditions:

Anatomic Stage IA Breast Cancer AJCC v8

Anatomic Stage IB Breast Cancer AJCC v8

Eligibility:

FEMALE

18+ years

Brief Summary

This is a prospective registry trial to determine the outcomes of single port robot-assisted nipple sparing mastectomy (SPrNSM) utilitzing the SP da Vinci surgical system.

Detailed Description

Robotic assisted nipple sparing mastectomies with multi-port robots, like the Da Vinci Xi, have been described previously but pose significant hurdles due to the small area like the breast. The Single...

Eligibility Criteria

Inclusion

  • 1\. Subjects age \>= 18 years who undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at UTSW

Exclusion

  • Subjects who are \<18 years of age
  • Subjects who do not undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at UTSW

Key Trial Info

Start Date :

February 1 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 24 2021

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT04866992

Start Date

February 1 2020

End Date

September 24 2021

Last Update

January 21 2022

Active Locations (1)

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1

UT Southwestern Medical Center

Dallas, Texas, United States, 75390