Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging

Withdrawn before enrolling · Not applicable

Conditions studied: Renal Tumors

In brief

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.

Key facts

Study ID

NCT01104389

Run by

Intuitive Surgical

People needed

0

Starts

2010-05-01

Last updated by the study team

2015-08-26

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Washington University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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