Ignite Creation Date:
2024-05-06 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05245812
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2022-02-08
Brief Title:
Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy
Sponsor:
Deborah Farr MD
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Safety and Feasibility of Robotic Single-port SP Nipple Sparing Mastectomy A Single Institution Single Arm Pilot Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
This is a single arm single-center prospective clinical trial designed to track the peri post-operative and oncologic outcomes when utilizing the da-Vinci single port SP robotic platform to perform robotic nipple sparing mastectomy rNSM and immediate breast reconstruction with tissue expandersimplants and acellular dermal matrix ADM - Alloderm for patients with breast cancer as well as those with a high risk for breast cancer
Safety and feasibility measures will be measured as primary outcome measures Oncological and patient satisfaction outcome measures will be measured Our hypothesis is that SPr-NSM is equal to open NSM in terms of safety feasibility and oncological outcomes with improved patient satisfaction as measured by nipple sensation and patient reported outcomes
Safety and feasibility measures will be measured as primary outcome measures Oncological and patient satisfaction outcome measures will be measured Our hypothesis is that SPr-NSM is equal to open NSM in terms of safety feasibility and oncological outcomes with improved patient satisfaction as measured by nipple sensation and patient reported outcomes
Detailed Description:
rNSM using the multi-port robotic platform followed by standard of care open breast reconstruction has been done successfully at multiple institutions worldwide with comparable if not superior outcomes to an open surgical approach This study explores this procedure with the Da Vinci SP robot with pre-pectoral reconstruction with acellular dermal matrix The patients will be evaluated per standard of care post-operative visits at 2 weeks 1 month and every 6 months for five years post operatively for subjective patient satisfaction and objectively for post-operative nipple sensation The patients will be monitored longitudinally for oncologic outcomes including the presence of a new breast cancer andor breast cancer recurrence Patients will be monitored for any complications related to rNSM and the use of ADM in expander and implant-based breast reconstruction
Investigational Device
The da Vinci SP Surgical System Model SP1098 is a software-controlled electro- mechanical system designed for surgeons to perform single port minimally invasive surgery The Model SP1098 Surgical System consists of a Surgeon Console a Patient Cart and a Vision Cart and is used with a Camera Instrument EndoWrist SP Instruments and Accessories
Indications for Use
The da Vinci SP Surgical System Model SP1098 is cleared for use in urologic surgical procedures that are appropriate for a single-port approach and transoral otolaryngology procedures restricted to T1 and T2 tumors This investigational study will evaluate device usage in nipple sparing mastectomy NSM procedures
Investigational Device
The da Vinci SP Surgical System Model SP1098 is a software-controlled electro- mechanical system designed for surgeons to perform single port minimally invasive surgery The Model SP1098 Surgical System consists of a Surgeon Console a Patient Cart and a Vision Cart and is used with a Camera Instrument EndoWrist SP Instruments and Accessories
Indications for Use
The da Vinci SP Surgical System Model SP1098 is cleared for use in urologic surgical procedures that are appropriate for a single-port approach and transoral otolaryngology procedures restricted to T1 and T2 tumors This investigational study will evaluate device usage in nipple sparing mastectomy NSM procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None