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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

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.

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Detailed Description

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Conditions

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Renal Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Fluorescence imaging

Intraoperatively acquire fluorescence images of renal tumors

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No