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Radiation Exposure Assessment in Fluoroscopy

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AdventHealth

Status

Completed

Conditions

Fluoroscopy; Adverse Effect
Radiation Exposure

Treatments

Radiation: Radiation exposure

Study type

Observational

Funder types

Other

Identifiers

NCT03985488
1434665

Details and patient eligibility

About

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

Full 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.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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