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

Clinical Evaluation of the OEC Elite MD for Vascular Procedures

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.

Study Overview

• Status: Completed
• Conditions: Interventional Vascular Conditions
• Intervention / Treatment: Device: Fluoroscopic imaging with the OEC Elite Device

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will be adults undergoing vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed.

Description

Inclusion Criteria:

1. Male or female between the ages of 18 and 85 years (≥18 and ≤85 years old);
2. Clinical indication for procedures including vascular, gastrointestinal (GI), urology or pain management for which mobile fluoroscopy has been prescribed for image guidance;
3. Able and willing to comply with study procedures; and
4. Able and willing to provide written informed consent to participate.

Exclusion Criteria:

1. Pregnant or suspected to be pregnant based on the opinion of and as documented by a medically qualified physician investigator;
2. Expected to be at increased risk due to study participation (e.g. due to allergies, sensitivities), in the medical opinion of an investigator; or
3. Previously participated in this study, or enrolled in another active GEHC study or other research study that could be expected to interfere with participation in study procedures, in the opinion of the investigator.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Subjects; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image Guidance Adequacy Collected Via Survey Questionnaire	Number of participants whose procedures were completed using the investigational device.	Approximately 2 months (duration of subject enrollment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Investigator Procedure Surveys Assessed by Survey Questionnaire	To collect image data acquired during clinical procedures and to collect investigator feedback via surveys on the use of the system during clinical procedures.	Approximately 2 months (duration of subject enrollment)

Collaborators and Investigators

• Sponsor: GE Healthcare

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 4, 2018
• Primary Completion (ACTUAL): May 15, 2018
• Study Completion (ACTUAL): May 29, 2018

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (ACTUAL): January 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 104-2017-GES-0005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes