Clinical Evaluation of the OEC Elite Vascular Mobile Fluoroscopy System

The purpose of the study is to collect survey data on the use of the OEC Elite Mobile Fluoroscopy System based on the routine clinical use of the device.

Study Overview

• Status: Terminated
• Conditions: Interventional Vascular Conditions
• Intervention / Treatment: Device: OEC Elite system

Detailed Description

This prospective clinical study is being conducted to acquire image guidance adequacy data from physicians conducting clinically-indicated vascular, gastrointestinal (GI), urology and pain management procedures for engineering use, as deemed appropriate by the Sponsor, for the investigational OEC Elite Mobile Fluoroscopy System (OEC Elite) in the vascular configuration. Clinical procedures included in this study will involve three (3) anatomical regions of interest - extremities and neck, thorax, and abdomen and pelvis. These regions are being targeted because they represent the range of clinical applications and anatomical regions intended for OEC Elite in the vascular configuration.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female between the ages of 18 and 75 years (≥18 and ≤75 years old);
2. Clinical indication for a vascular, gastrointestinal (GI), urology or pain management procedure for which mobile fluoroscopy has been prescribed;
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OEC Elite Imaging Arm; Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system	Device: OEC Elite system; Adults undergoing vascular, gastrointestinal (GI), urology or pain management procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imaging Guidance Adequacy Assessed by Number of Questionnaires	Per-subject investigator report for procedure completion using the Investigational Device	2 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Investigator Procedure Surveys Assessed by Survey Questionnaire	The total number of per subject survey completion reflecting the investigator opinion of procedures completed with the investigational device	2 months

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: Theodore Rapanos, Hamilton General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Actual): July 7, 2017
• Study Completion (Actual): July 7, 2017

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 30, 2017

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 104-2016-PTHS-0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes