Radiation Exposure Assessment in Fluoroscopy

Completed

• Conditions: Radiation Exposure; Fluoroscopy; Adverse Effect
• Interventions: Radiation: Radiation exposure

• Registration Number: NCT03985488
• Lead Sponsor: AdventHealth

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2019-05-06
• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-12
• Study First Posted: 2019-06-13
• Primary Completion: 2019-10-31
• Study Completion: 2020-01-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fluoroshield Device	Radiation exposure	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.
Eview Fluoroscopy Machine	Radiation exposure	The Eview Fluoroscopy Machine is the standard of care fluoro machine used in endoscopy.

Primary Outcome Measures

Name	Time	Method
Degree of exposure measured by Dap meter and cumulative air KERMA	1 day	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).

Trial Locations

Locations (1)

Center for Interventional Endoscopy; 🇺🇸 Orlando, Florida, United States