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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


N/A
18 Years
80 Years
Not Enrolling
Both
Renal Tumors

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

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.

Outcome Description:

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.

Outcome Time Frame:

Intraoperatively

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

ISI-FHU-2010-01

NCT ID:

NCT01104389

Start Date:

May 2010

Completion Date:

Related Keywords:

  • Renal Tumors
  • Kidney Neoplasms

Name

Location

Washington UniversitySt. Louis, Missouri  63110