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

This study has been terminated.
(Study was terminated. P.I. left the institution.)
Sponsor:
Collaborator:
Weiss Memorial Hospital
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01136811
First received: May 28, 2010
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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. 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. The investigators are seeking approval by the FDA to utilize the daVinci Surgical System in vascular surgery.


Condition Intervention
Lower Extremity Occlusive Disease
 Device: daVinci Surgical System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Computer Assisted Surgery for Use in Vascular Surgery Procedures

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • patency of graft anastomosis [ Time Frame: 30 Day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time for femoral artery dissection and anastomosis [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Improvement in ABI measurement of 0.15 or better [ Time Frame: 3 month, 6 month, 1 year ] [ Designated as safety issue: No ]
  • death [ Time Frame: 30day, 1 year ] [ Designated as safety issue: No ]
    death


Enrollment: 10
Study Start Date: June 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: daVinci Surgical System

    use of computer assisted surgical device in vascular surgery

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

    Other Name: DaVinci Surgical System
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with significant femoropopliteal or tibial occlusivedisease 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 pre-operative 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136811

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Sponsors and Collaborators
University of Chicago
Weiss Memorial Hospital
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01136811     History of Changes
Other Study ID Numbers: 17002A
Study First Received: May 28, 2010
Last Updated: January 9, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013