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

Intuitive Surgical

Status: Withdrawn

Conditions: Renal Tumors

Treatments: Device: Fluorescence imaging

Study type: Interventional

Funder types: Industry

Identifiers

NCT01104389

ISI-FHU-2010-01

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.