Safety and Efficacy of Computer Assisted Surgery for Use in Vascular Surgery Procedures

University of Chicago2 sites in 1 country11 target enrollmentJune 2009

ConditionsLower Extremity Occlusive Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lower Extremity Occlusive Disease
Sponsor: University of Chicago
Enrollment: 11
Locations: 2
Primary Endpoint: Patency of Graft Anastomosis
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the preliminary safety and efficacy of the daVinci surgical system (computer-assisted surgery) for use in vascular surgery procedures. Although the daVinci Surgical System is FDA approved and widely used for surgical procedures for urology, cardiac, general, and gynecologic procedures, it is not currently approved specifically for use in vascular surgery and the FDA has required the PI to conduct a small feasibility study under an IDE. The investigators are seeking approval by the FDA to utilize the daVinci Surgical System in vascular surgery and to conduct a future clinical trial.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

March 2011

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Chicago

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with significant femoropopliteal or tibial occlusive disease not amenable to catheter directed therapy (ie angioplasty/stenting). Symptoms include lifestyle-limiting claudication, rest pain and/or tissue loss.
•Patients with an ABI between 0.2 and 0.
•Femoropopliteal disease visible on color duplex ultrasound (DUS)
•Patent and minimally diseased common femoral and proximal superficial artery
•Patients with American Society of Anesthesiology (ASA) I, II or III classification
•PT/PTT, EKG, HbA1c, liver function, within normal ranges within 30 days prior to procedure or stable over the last 6 months.
•Current University of Chicago Medical Center Lab standards will be used. Pulmonary function will be assessed as needed by preoperative anesthesia evaluation. (Generally for infrainguinal procedures, pulmonary function is not assessed)
•Body Mass Index (BMI) \<40