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This study has been withdrawn prior to enrollment.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)
Information provided by:
First received: April 7, 2010
Last updated: August 3, 2011
Last verified: August 2011
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.
Device: Fluorescence imaging
Intervention Model: Single Group Assignment
Masking: Open Label
||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
Primary Outcome Measures:
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:
| Study Start Date:
| Estimated Primary Completion Date:
||July 2010 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01104389
|St Louis, Missouri, United States |
No publications provided
ClinicalTrials.gov processed this record on November 25, 2014
||Song Liu/Clinical Trial Associate, Intuitive Surgical
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 7, 2010
||August 3, 2011
||United States: Institutional Review Board