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

Anatomic Stage II Breast Cancer AJCC v8 Clinical Trial

Official title:
Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy

Clinical Trial 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.

Clinical Trial 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-Port da Vinci SP (Intuitive Surgical), which was designed for application to small cavity surgery, may be more appropriately suited for this procedure. This is a prospective registry trial to study the outcomes of performing a single-port robot-assisted nipple sparing mastectomy. Subjects who undergo rNSM and bilateral breast reconstruction of the affected breast via single site small hidden axillary scar technique will be offered participation in the prospective registry trial at their pre-operative visit in the UT Southwestern Breast Clinic. The patient will then be seen at their regularly scheduled clinic appointments at 2 weeks, 1 month, 6 months, and 1 year post operatively at both Breast and Plastics and Reconstructive Surgery (PRS) departments. Outcomes will be tracked in a prospectively kept electronic registry. ;

Study Design

Related Conditions & MeSH terms

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage IA Breast Cancer AJCC v8
  • Anatomic Stage IB Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage IIA Breast Cancer AJCC v8
  • Anatomic Stage IIB Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • BRCA1 Mutation
  • BRCA2 Mutation
  • Breast Neoplasms
  • Carcinoma in Situ
  • Carcinoma, Ductal
  • Carcinoma, Intraductal, Noninfiltrating
  • Ductal Carcinoma in Situ
  • Prognostic Stage I Breast Cancer AJCC v8
  • Prognostic Stage II Breast Cancer AJCC v8
Clinical Trial Details
NCT number NCT04866992
Study type Observational
Source University of Texas Southwestern Medical Center
Contact
Status Completed
Phase
Start date February 1, 2020
Completion date September 24, 2021
View Details
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