Clinical Evaluation of the OEC Elite Vascular Mobile Fluoroscopy System

Not Applicable

Terminated

• Conditions: Interventional Vascular Conditions
• Interventions: Device: OEC Elite system

• Registration Number: NCT03096483
• Lead Sponsor: GE Healthcare

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-03-16
• Study First Submitted QC: 2017-03-24
• Study First Posted: 2017-03-30
• Study Start: 2017-06-19
• Primary Completion: 2017-07-07
• Study Completion: 2017-07-07
• Results First Submitted: 2017-11-14
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-05
• Last Update Submitted: 2019-03-05
• Results First Posted: 2019-03-27
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OEC Elite Imaging Arm	OEC Elite system	Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system

Primary Outcome Measures

Name	Time	Method
Imaging Guidance Adequacy Assessed by Number of Questionnaires	2 Months	Per-subject investigator report for procedure completion using the Investigational Device

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada