Trial Outcomes & Findings for Safety and Efficacy of Computer Assisted Surgery for Use in Vascular Surgery Procedures (NCT NCT01136811)

NCT ID: NCT01136811

Last Updated: 2021-02-26

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: 30 Day
• Results posted on: 2021-02-26

Participant Flow

Participant milestones

Measure	Computer Assisted Surgery 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
Overall Study STARTED	11
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Measure	Computer Assisted Surgery 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
Overall Study Physician Decision	11

Baseline Characteristics

Trial terminated by Principal Investigator and the Principal Investigator has left the institution.

Baseline characteristics by cohort

Measure	Computer Assisted Surgery n=11 Participants 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
Age, Categorical <=18 years	0 Participants Trial terminated by Principal Investigator and the Principal Investigator has left the institution.
Age, Categorical Between 18 and 65 years	0 Participants Trial terminated by Principal Investigator and the Principal Investigator has left the institution.
Age, Categorical >=65 years	0 Participants Trial terminated by Principal Investigator and the Principal Investigator has left the institution.
Sex/Gender, Customized	0 Participants The PI has left the institution since 2011. No one associated with this study works at the institution currently. The current department staff have no access to the data. Per IRB records, no analysis was done, the trial was terminated by Principal Investigator and the Principal Investigator has left the institute. All efforts have been done to contact the PI and to gather data.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants Trial terminated by Principal Investigator and the Principal Investigator has left the institution.
Race (NIH/OMB) Asian	0 Participants Trial terminated by Principal Investigator and the Principal Investigator has left the institution.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants Trial terminated by Principal Investigator and the Principal Investigator has left the institution.
Race (NIH/OMB) Black or African American	0 Participants Trial terminated by Principal Investigator and the Principal Investigator has left the institution.
Race (NIH/OMB) White	0 Participants Trial terminated by Principal Investigator and the Principal Investigator has left the institution.
Race (NIH/OMB) More than one race	0 Participants Trial terminated by Principal Investigator and the Principal Investigator has left the institution.
Race (NIH/OMB) Unknown or Not Reported	0 Participants Trial terminated by Principal Investigator and the Principal Investigator has left the institution.
Region of Enrollment United States	11 participants n=11 Participants

PRIMARY outcome

Timeframe: 30 Day

Population: The PI has left the institution since 2011. No one associated with this study works at the institution currently. The current department staff have no access to the data. Per IRB records, no analysis was done, the trial was terminated by Principal Investigator and the Principal Investigator has left the institute. All efforts have been done to contact the PI and to gather data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 day

Population: The PI has left the institution since 2011. No one associated with this study works at the institution currently. The current department staff have no access to the data. Per IRB records, no analysis was done, the trial was terminated by Principal Investigator and the Principal Investigator has left the institute. All efforts have been done to contact the PI and to gather data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 month, 6 month, 1 year

Population: The PI has left the institution since 2011. No one associated with this study works at the institution currently. The current department staff have no access to the data. Per IRB records, no analysis was done, the trial was terminated by Principal Investigator and the Principal Investigator has left the institute. All efforts have been done to contact the PI and to gather data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30day, 1 year

Population: The PI has left the institution since 2011. No one associated with this study works at the institution currently. The current department staff have no access to the data. Per IRB records, no analysis was done, the trial was terminated by Principal Investigator and the Principal Investigator has left the institute. All efforts have been done to contact the PI and to gather data.

death

Outcome measures

Outcome data not reported

Adverse Events

Computer Assisted Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shirley Rodriguez

University of Chicago

Phone: 773-834-4337

Email: srodrigu@surgery.bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place