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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01104389
Recruitment Status : Withdrawn (Study was never started)
First Posted : April 15, 2010
Last Update Posted : August 26, 2015
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Renal Tumors Device: Fluorescence imaging

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : May 2010
Estimated Primary Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Device: Fluorescence imaging
    Intraoperatively acquire fluorescence images of renal tumors

Outcome Measures

Primary Outcome Measures :
  1. 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. [ Time Frame: Intraoperatively ]
    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.


Secondary Outcome Measures :
  1. Include but not limited to the rate of positive surgical margins, incidence of complications, estimated blood loss and length of stay. [ Time Frame: up to 3 weeks postoperatively ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104389


Locations
United States, Missouri
Washington University
St Louis, Missouri, United States
Sponsors and Collaborators
Intuitive Surgical
More Information

Responsible Party: Song Liu/Clinical Trial Associate, Intuitive Surgical
ClinicalTrials.gov Identifier: NCT01104389     History of Changes
Other Study ID Numbers: ISI-FHU-2010-01
First Posted: April 15, 2010    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases