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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Renal Tumors

Intervention / Treatment
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* Device: Fluorescence imaging


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Fluorescence imaging|Intraoperatively acquire fluorescence images of renal tumors|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |