A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging of Renal Cortical Tumors

Intuitive Surgical1 site in 1 countryMay 2010

ConditionsRenal Tumors

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Renal Tumors
Sponsor: Intuitive Surgical
Locations: 1
Primary Endpoint: The rate of good or excellent fluorescence images achieved intraoperatively. It will be measured by the correlation of the ultrasound imaging with the fluorescence imaging.
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging of Renal Cortical Tumors. To determine the feasibility of the fluorescence imaging on the da Vinci Surgical System in robotic partial nephrectomy procedures and report perioperative outcomes.

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

July 2010

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Intuitive Surgical

Eligibility Criteria

Inclusion Criteria

•Ages of 18 to 80 years.
•Urine pregnancy test negative for women of childbearing potential prior to surgery
•Subject is able to comply with the study procedures
•A CT or MRI preoperative assessment of renal cortical tumor
•The renal tumor must be stage T1a-b - T2
•Written informed consent.

Exclusion Criteria

•Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, as total bilirubin \>1.5 X normal and/or SGOT \>2X normal
•Subject has uremia, serum creatinine \>2.0 mg/dl.
•Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes
•Subject in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered
•Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
•Subject is pregnant or lactating
•Subjects actively participating in another drug, biologic and/or device protocol
•The presence of medical conditions contraindicating general anesthesia or standard surgical approaches.

Outcomes

Primary Outcomes

The rate of good or excellent fluorescence images achieved intraoperatively. It will be measured by the correlation of the ultrasound imaging with the fluorescence imaging.

Time Frame: Intraoperatively

The feasibility of using the fluorescence imaging on the da Vinci Surgical System to detect renal cortical tumors will be measured by the rate of good or excellent images achieved intraoperatively.

Secondary Outcomes

Include but not limited to the rate of positive surgical margins, incidence of complications, estimated blood loss and length of stay.(up to 3 weeks postoperatively)