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

NCT01104389 | Withdrawn

• 1 other identifier: ISI-FHU-2010-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Tumors

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Interventions

Fluorescence imaging DEVICE

Intraoperatively acquire fluorescence images of renal tumors

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (1)

Washington University

St Louis, Missouri, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Optical Imaging

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 7, 2010
• First Posted: April 15, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2010
• Last Updated: August 26, 2015

Record last verified: 2015-08

Locations

US (1)