Ignite Creation Date:
2024-05-06 @ 1:53 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01925677
Status:
COMPLETED
Last Update Posted:
2019-11-20
First Post:
2013-08-06
Brief Title:
Robotic Single Port Donor Nephrectomy
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Use of the Intuitive Surgical da Vinci Single-Site With Instruments and Accessories for Single-Port Laparoscopic Nephrectomies
Status:
COMPLETED
Status Verified Date:
2019-11
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:
Feasibility study on robotic-assisted single-site donor nephrectomy utilizing da Vinci instrumentation and Single-Site platforms
Detailed Description:
Our center has performed over 200 single-port donor nephrectomies with standard laparoscopy and has reported patient benefits associated with a single port approach The single port robotic platform offers the potential to ameliorate the significant technical and ergonomic challenges that currently limit more widespread application of single port donor surgery After being informed of the potential risks and off-label use of the da Vinci Single-Site approach in our study patients will undergo a robotic-assisted single-site donor nephrectomy performed by a two-surgeon team utilizing existing da Vinci instrumentation and Single-Site platforms Renal mobilization and vascular dissection will be performed with manual laparoscopy performed for vascular division utilizing stapling devices
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