NCT03096483

Clinical Evaluation of the OEC Elite Vascular Mobile Fluoroscopy System

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Interventional Vascular Conditions

Interventions

Type	Name	Description
DEVICE	OEC Elite system	Adults undergoing vascular, gastrointestinal (GI), urology or pain management procedures

Timeline

• Start date: 2017-06-19
• Primary completion: 2017-07-07
• Completion: 2017-07-07
• First posted: 2017-03-30
• Last updated: 2019-03-27
• Results posted: 2019-03-27

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study