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

Renal Tumors Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01104389
• Other study ID #: ISI-FHU-2010-01
• Status: Withdrawn
• Phase: N/A
• First received: April 7, 2010
• Last updated: August 24, 2015
• Start date: May 2010

Study information

• Verified date: August 2015
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Renal Tumors

Intervention

Device:
• Fluorescence imaging
Intraoperatively acquire fluorescence images of renal tumors

Locations

Country	Name	City	State
United States	Washington University	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	Intraoperatively	Yes
Secondary	Include but not limited to the rate of positive surgical margins, incidence of complications, estimated blood loss and length of stay.		up to 3 weeks postoperatively	No