Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-01-01 @ 7:57 AM
Study NCT ID:
NCT04866992
Status:
COMPLETED
Last Update Posted:
2022-01-21
First Post:
2021-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy (SPrNSM)
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPrNSM
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-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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: