Clinical Evaluation of the OEC Elite Vascular Mobile Fluoroscopy System

General Electric (GE)

Status: Terminated

Conditions: Interventional Vascular Conditions

Treatments: Device: OEC Elite system

Study type: Interventional

Funder types: Industry

Identifiers

NCT03096483

104-2016-PTHS-0005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

OEC Elite Imaging Arm

Experimental group

Description:

Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system

Treatment:

Device: OEC Elite system