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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
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

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 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

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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
GE Healthcare
  Study Documents (Full-Text)

Documents provided by GE Healthcare:

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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT03417713     History of Changes
Other Study ID Numbers: 104-2017-GES-0005
First Posted: January 31, 2018    Key Record Dates
Results First Posted: November 29, 2018
Last Update Posted: November 29, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes