Clinical Evaluation of the OEC Elite MD for Vascular Procedures at Hamilton General Hospital
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|ClinicalTrials.gov Identifier: NCT03417713|
Recruitment Status : Completed
First Posted : January 31, 2018
Results First Posted : November 29, 2018
Last Update Posted : November 29, 2018
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.
|Condition or disease||Intervention/treatment|
|Interventional Vascular Conditions||Device: Fluoroscopic imaging with the OEC Elite Device|
|Study Type :||Observational|
|Actual Enrollment :||33 participants|
|Official Title:||Clinical Evaluation of the OEC Elite MD for Vascular Procedures|
|Actual Study Start Date :||April 4, 2018|
|Actual Primary Completion Date :||May 15, 2018|
|Actual Study Completion Date :||May 29, 2018|
This group/cohort is expected to be representative of the general population that would require mobile fluoroscopic imaging with C-arm devices, such as OEC Elite.
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.
- Image Guidance Adequacy Collected Via Survey Questionnaire [ Time Frame: Approximately 2 months (duration of subject enrollment) ]Number of participants whose procedures were completed using the investigational device.
- Number of Investigator Procedure Surveys Assessed by Survey Questionnaire [ Time Frame: Approximately 2 months (duration of subject enrollment) ]To collect image data acquired during clinical procedures and to collect investigator feedback via surveys on the use of the system during clinical procedures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417713
|Hamilton General Hospital|
|Hamilton, Ontario, Canada, L8L 2X2|