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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 before completing study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01136811
First Posted: June 3, 2010
Last Update Posted: November 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Louis A. Weiss Memorial Hospital
Information provided by (Responsible Party):
University of Chicago
  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. 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.

Condition Intervention
Lower Extremity Occlusive Disease Device: Computer assisted surgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 ]

Secondary Outcome Measures:
  • Time for femoral artery dissection and anastomosis [ Time Frame: 1 day ]
  • Improvement in ABI measurement of 0.15 or better [ Time Frame: 3 month, 6 month, 1 year ]
  • death [ Time Frame: 30day, 1 year ]
    death


Enrollment: 8
Study Start Date: June 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: DaVinci Surgical System

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Louis A. Weiss Memorial Hospital
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01136811     History of Changes
Other Study ID Numbers: 17002A
First Submitted: May 28, 2010
First Posted: June 3, 2010
Last Update Posted: November 18, 2014
Last Verified: November 2014