Radiation Exposure Assessment in Fluoroscopy

Radiation Exposure Clinical Trial

Official title:

Prospective Registry of Radiation Exposure Measurement in Procedures Utilizing Fluoroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03985488
• Other study ID #: 1434665
• Status: Completed
• Start date: May 6, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: April 2020
• Source: AdventHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There has been increasing awareness regarding the risk of radiation exposure to patients and providers when performing procedures requiring fluoroscopic guidance.

Description:

Fluoroscopy guidance is routinely used in many endoscopic procedures per standard-of-care practice and there is increasing effort to minimize the degree of radiation exposure to patients and providers during fluoroscopy usage. The current fluoroscopy machine used per standard-of-care practice at the Center for Interventional Endoscopy is the Eview machine (Omega Medical Imaging, Orlando, FL, USA). Recently, CA-100S technology (FluoroShield, Omega Medical Imaging) has been developed in an effort to further reduce the degree of radiation exposure to patients and provides. This technology is an additional component that can be fitted to the preexisting Eview fluoroscopy machine, in order to further filter radiation that has passed through the pre-existing machine. The investigators will be performing this study to determine the degree of radiation exposure to patients and providers when using the Eview fluoroscopy machine, with and without the FluoroShield radiation exposure reduction system.

There has been increasing awareness regarding the risk of radiation exposure to patients and providers when performing procedures requiring fluoroscopic guidance. In a prior study, the Eview machine, which is currently used for fluoroscopy guidance at the Center for Interventional Endoscopy, was shown to decrease, but not completely eliminate, radiation exposure when compared to C-arm type of fluoroscopy machines (GE Healthcare, Wauwatosa, WI, USA). Recently, the FluoroShield technology (Omega Medical Imaging) has been developed in an effort to further reduce the degree of radiation exposure to patients and provides. This technology is an additional component that can be fitted to the preexisting Eview fluoroscopy machines, in order to further filter radiation that has passed through the pre-existing machine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 31, 2020
• Est. primary completion date: October 31, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older

• Having an endoscopy with fluoroscopy

Exclusion Criteria:

• Less than 18 years of age

• Not having an endoscopy with fluoroscopy

Related Conditions & MeSH terms

• Fluoroscopy; Adverse Effect
• Radiation Exposure

Intervention

Radiation:
• Radiation exposure
Radiation exposure via Eview Fluoroscopy machine.

Locations

Country	Name	City	State
United States	Center for Interventional Endoscopy	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AdventHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of exposure measured by Dap meter and cumulative air KERMA	Measurement of the degree of radiation exposure to patients and providers when performing endoscopic procedures with fluoroscopy guidance, with and without the FluroShield radiation exposure reduction system will be measured. The data will be collected in microgray per meter squared (Dap meter) and milligray (cumulative air KERMA).	1 day