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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

Tracking Information
First Submitted Date January 12, 2018
First Posted Date January 31, 2018
Results First Submitted Date July 11, 2018
Results First Posted Date November 29, 2018
Last Update Posted Date November 29, 2018
Actual Study Start Date April 4, 2018
Actual Primary Completion Date May 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 18, 2018)
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.
Original Primary Outcome Measures
 (submitted: January 24, 2018)
Image Guidance Adequacy Collected Via Survey Questionnaire [ Time Frame: Approximately 2 months (duration of subject enrollment) ]
To collect investigator feedback on imaging guidance adequacy of the OEC Elite during clinical procedures.
Change History Complete list of historical versions of study NCT03417713 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 24, 2018)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Evaluation of the OEC Elite MD for Vascular Procedures at Hamilton General Hospital
Official Title Clinical Evaluation of the OEC Elite MD for Vascular Procedures
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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.
Study Groups/Cohorts 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.
Intervention: Device: Fluoroscopic imaging with the OEC Elite Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 18, 2018)
33
Original Estimated Enrollment
 (submitted: January 24, 2018)
40
Actual Study Completion Date May 29, 2018
Actual Primary Completion Date May 15, 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03417713
Other Study ID Numbers 104-2017-GES-0005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party GE Healthcare
Study Sponsor GE Healthcare
Collaborators Not Provided
Investigators Not Provided
PRS Account GE Healthcare
Verification Date October 2018