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

NCT01136811 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-02-26

Study results available
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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.

Conditions

  • Lower Extremity Occlusive Disease

Interventions

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

Sponsors & Collaborators

  • Louis A. Weiss Memorial Hospital

    collaborator OTHER

  • University of Chicago

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01136811 on ClinicalTrials.gov