Radiation Exposure Assessment in Fluoroscopy

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

Detailed Description
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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.

Official Title
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Prospective Registry of Radiation Exposure Measurement in Procedures Utilizing Fluoroscopy

Conditions
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Fluoroscopy; Adverse Effect, Radiation Exposure

Intervention / Treatment
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* Radiation: Radiation exposure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eview Fluoroscopy Machine<br>The Eview Fluoroscopy Machine is the standard of care fluoro machine used in endoscopy. | Radiation: Radiation exposure<br>* Radiation exposure via Eview Fluoroscopy machine.<br>|
| Fluoroshield Device<br>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. | Radiation: Radiation exposure<br>* Radiation exposure via Eview Fluoroscopy machine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopy, fluoroscopy, radiation exposure