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

Not Applicable

Terminated

• Conditions: Lower Extremity Occlusive Disease
• Interventions: Device: Computer assisted surgery

• Registration Number: NCT01136811
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-05-28
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2020-11-20
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-09
• Last Update Submitted: 2021-02-09
• Results First Posted: 2021-02-26
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Computer assisted surgery	Computer assisted surgery	-

Primary Outcome Measures

Name	Time	Method
Patency of Graft Anastomosis	30 Day

Secondary Outcome Measures

Name	Time	Method
Death	30day, 1 year	death
Time for Femoral Artery Dissection and Anastomosis	1 day
Improvement in ABI Measurement of 0.15 or Better	3 month, 6 month, 1 year

Trial Locations

Locations (2)

Weiss Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

The University of Chicago; 🇺🇸 Chicago, Illinois, United States