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

Lower Extremity Occlusive Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01136811
• Other study ID #: 17002A
• Status: Terminated
• Phase: N/A
• Start date: June 2009
• Est. completion date: March 2011

Study information

• Verified date: February 2021
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Extremity Occlusive Disease

Intervention

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

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois
United States	Weiss Memorial Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Louis A. Weiss Memorial Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency of Graft Anastomosis		30 Day
Secondary	Time for Femoral Artery Dissection and Anastomosis		1 day
Secondary	Improvement in ABI Measurement of 0.15 or Better		3 month, 6 month, 1 year
Secondary	Death	death	30day, 1 year