Clinical Evaluation of the OEC Elite Vascular Mobile Fluoroscopy System

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of the OEC Elite Vascular Mobile Fluoroscopy System

Conditions
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Interventional Vascular Conditions

Intervention / Treatment
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* Device: OEC Elite system


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |