Ignite Creation Date:
2024-05-06 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03417713
Status:
COMPLETED
Last Update Posted:
2018-11-29
First Post:
2018-01-12
Brief Title:
Clinical Evaluation of the OEC Elite MD for Vascular Procedures at Hamilton General Hospital
Sponsor:
GE Healthcare
Organization:
GE Healthcare
Study Overview
Official Title:
Clinical Evaluation of the OEC Elite MD for Vascular Procedures
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 subjects 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 hisher 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
Up to 40 eligible subjects will be enrolled and have their clinically indicated procedure completed using the investigational device
Following completion of each subjects 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 hisher 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None