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

February 9, 2021 updated by: University of Chicago
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University Of Chicago
      • Chicago, Illinois, United States, 60640
        • Weiss Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Computer assisted surgery
Device: 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

Other Names:
  • DaVinci Surgical System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patency of Graft Anastomosis
Time Frame: 30 Day
30 Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time for Femoral Artery Dissection and Anastomosis
Time Frame: 1 day
1 day
Improvement in ABI Measurement of 0.15 or Better
Time Frame: 3 month, 6 month, 1 year
3 month, 6 month, 1 year
Death
Time Frame: 30day, 1 year
death
30day, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Louis A. Weiss Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

May 28, 2010

First Submitted That Met QC Criteria

June 2, 2010

First Posted (ESTIMATE)

June 3, 2010

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 17002A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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