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This study has been withdrawn prior to enrollment.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

Tracking Information
First Received Date ^ICMJE	April 7, 2010
Last Updated Date	August 3, 2011
Start Date ^ICMJE	May 2010
Estimated Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 13, 2010)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01104389 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 13, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label
Condition ^ICMJE	Renal Tumors
Intervention ^ICMJE	Device: Fluorescence imaging Intraoperatively acquire fluorescence images of renal tumors
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Estimated Enrollment ^ICMJE	20
Completion Date	Not Provided
Estimated Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01104389
Other Study ID Numbers ^ICMJE	ISI-FHU-2010-01
Has Data Monitoring Committee	No
Responsible Party	Song Liu/Clinical Trial Associate, Intuitive Surgical
Study Sponsor ^ICMJE	Intuitive Surgical
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Intuitive Surgical
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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