Clinical Trials Directory

Trials / Completed

CompletedNCT01925677

Robotic Single Port Donor Nephrectomy

Use of the Intuitive Surgical da Vinci® Single-Site™ With Instruments and Accessories for Single-Port Laparoscopic Nephrectomies

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
3 (actual)
Sponsor
University of Maryland, Baltimore · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEda Vinci® Single-Site™Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System.

Timeline

Start date
2015-01-01
Primary completion
2017-08-01
Completion
2017-08-01
First posted
2013-08-20
Last updated
2019-11-20
Results posted
2019-11-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01925677. Inclusion in this directory is not an endorsement.