Clinical Evaluation of the OEC Elite Vascular Mobile Fluoroscopy System

Interventional Vascular Conditions Clinical Trial

Official title:

Clinical Evaluation of the OEC Elite Vascular Mobile Fluoroscopy System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03096483
• Other study ID #: 104-2016-PTHS-0005
• Status: Terminated
• Phase: N/A
• Start date: June 19, 2017
• Est. completion date: July 7, 2017

Study information

• Verified date: March 2019
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 7, 2017
• Est. primary completion date: July 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Interventional Vascular Conditions

Intervention

Device:
• OEC Elite system
Adults undergoing vascular, gastrointestinal (GI), urology or pain management procedures

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Imaging Guidance Adequacy Assessed by Number of Questionnaires	Per-subject investigator report for procedure completion using the Investigational Device	2 Months
Secondary	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