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OpenTrials
Completed

NCT Number: NCT03985488

Radiation Exposure Assessment in Fluoroscopy

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Interventional Endoscopy

Orlando, Florida, 32803, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiation exposure

Radiation

Radiation exposure via Eview Fluoroscopy machine.

Primary outcomes

  1. Degree of exposure measured by Dap meter and cumulative air KERMA

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Official study title

Prospective Registry of Radiation Exposure Measurement in Procedures Utilizing Fluoroscopy

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jun 13, 2019
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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