Trials / Completed

CompletedNCT04866992

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

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

Status: Completed
Phase: —
Study type: Observational
Enrollment: 10 (actual)

Sponsor: University of Texas Southwestern Medical Center · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Accepted

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-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.

Conditions

Timeline

Start date: 2020-02-01
Primary completion: 2021-07-14
Completion: 2021-09-24
First posted: 2021-04-30
Last updated: 2022-01-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04866992. Inclusion in this directory is not an endorsement.