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

Interventional Vascular Conditions Clinical Trial

Official title:

Clinical Evaluation of the OEC Elite MD for Vascular Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03417713
• Other study ID #: 104-2017-GES-0005
• Status: Completed
• Start date: April 4, 2018
• Est. completion date: May 29, 2018

Study information

• Verified date: October 2018
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 29, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Interventional Vascular Conditions

Intervention

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.

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)