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This study has been withdrawn prior to enrollment.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

April 7, 2010
August 3, 2011
May 2010
July 2010   (final data collection date for primary 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. [ 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.
Same as current
Complete list of historical versions of study NCT01104389 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging
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

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Renal Tumors
Device: Fluorescence imaging
Intraoperatively acquire fluorescence images of renal tumors
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
20
Not Provided
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01104389
ISI-FHU-2010-01
No
Song Liu/Clinical Trial Associate, Intuitive Surgical
Intuitive Surgical
Not Provided
Not Provided
Intuitive Surgical
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP