NCT03417713

Clinical Evaluation of the OEC Elite MD for Vascular Procedures at Hamilton General Hospital

Clinical Evaluation of the OEC Elite MD for Vascular Procedures

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect feedback on imaging guidance adequacy from physicians who use the OEC™ Elite CFD Mobile Fluoroscopy System-Motorized Configuration to perform surgical procedures for which the use of mobile fluoroscopy is prescribed per standard of care. Up to 40 eligible subjects will be enrolled and have their clinically indicated procedure completed using the investigational device. Following completion of each subject's procedure, the investigators will complete a User Survey specific to the workflow and guidance adequacy of the OEC Elite device. The survey will consist of a series of questions on the use of the system as well as anonymized image data. After all subjects' procedures are completed at a given site, the site investigator will review survey data from the study subjects enrolled at the site and document his/her assessment of the overall acceptability of the system for use in a clinical environment. There is no statistical hypothesis being tested in this study. Results will be summarized using descriptive statistics.

Conditions

• Interventional Vascular Conditions

Interventions

Type	Name	Description
DEVICE	Fluoroscopic imaging with the OEC Elite Device	Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed.

Timeline

• Start date: 2018-04-04
• Primary completion: 2018-05-15
• Completion: 2018-05-29
• First posted: 2018-01-31
• Last updated: 2018-11-29
• Results posted: 2018-11-29

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study