Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04866992
Status:
COMPLETED
Last Update Posted:
2022-01-21
First Post:
2021-04-01
Brief Title:
Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy SPrNSM
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
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:
None
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?:
None