Clinical trial NCT03417713: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interventional Vascular Conditions
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2018-01-31
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Image Guidance Adequacy Collected Via Survey Questionnaire
timeFrame: Approximately 2 months (duration of subject enrollment)
Secondary outcomes:
measure: Number of Investigator Procedure Surveys Assessed by Survey Questionnaire
timeFrame: Approximately 2 months (duration of subject enrollment)
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
References: