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

Stopped early · Not applicable

Conditions studied: Lower Extremity Occlusive Disease

In brief

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.

Key facts

Study ID

NCT01136811

Run by

University of Chicago

People needed

11

Starts

2009-06-01

Expected to finish

2011-03-01

Last updated by the study team

2021-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 0.8.
• 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

You may not qualify if…

• Previous surgery in the inguinal region (ie: prior femoral artery dissection)
• Myocardial infarction (MI) within the last 6 months
• Laboratory evidence of hypercoagulable state and/or connective tissue disease
• Pregnant women
• History of non-compliance with medical care

Where it is running

• The University of Chicago — Chicago, Illinois, United States
• Weiss Memorial Hospital — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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