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

The University of Chicago

Status: Terminated

Conditions: Lower Extremity Occlusive Disease

Treatments: Device: Computer assisted surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01136811

17002A

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 0.8.
• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Computer assisted surgery

Experimental group

Treatment:

Device: Computer assisted surgery