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

This study has been withdrawn prior to enrollment.
(Study was never started)
Sponsor:
Information provided by:
Intuitive Surgical
ClinicalTrials.gov Identifier:
NCT01104389
First received: April 7, 2010
Last updated: August 3, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention
Renal Tumors
 Device: Fluorescence imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Intuitive Surgical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Fluorescence imaging
    Intraoperatively acquire fluorescence images of renal tumors
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104389

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

No publications provided

Responsible Party: Song Liu/Clinical Trial Associate, Intuitive Surgical
ClinicalTrials.gov Identifier: NCT01104389     History of Changes
Other Study ID Numbers: ISI-FHU-2010-01
Study First Received: April 7, 2010
Last Updated: August 3, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013