Completed

NCT Number: NCT03417713

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

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.

Completed

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Key information

Conditions

Interventional Vascular Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Pregnant or suspected to be pregnant based on the opinion of and as documented by a medically qualified physician investigator;
Expected to be at increased risk due to study participation (e.g. due to allergies, sensitivities), in the medical opinion of an investigator; or
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.

Treatment and study plan

Fluoroscopic imaging with the OEC Elite Device

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 outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study title

Clinical Evaluation of the OEC Elite MD for Vascular Procedures

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Jan 31, 2018
Registry last updated: Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.