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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Lower Extremity Occlusive Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Computer assisted surgery

Group Type EXPERIMENTAL

Computer assisted surgery

Intervention Type DEVICE

use of computer assisted surgical device in vascular surgery

completion of the proximal (femoral) anastomosis portion of a lower extremity bypass procedure

Interventions

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Computer assisted surgery

use of computer assisted surgical device in vascular surgery

completion of the proximal (femoral) anastomosis portion of a lower extremity bypass procedure

Intervention Type DEVICE

Other Intervention Names

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DaVinci Surgical System

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No