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Radiation Exposure Assessment in Fluoroscopy

Prospective Registry of Radiation Exposure Measurement in Procedures Utilizing Fluoroscopy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03985488
Enrollment
150
Registered
2019-06-13
Start date
2019-05-06
Completion date
2020-01-31
Last updated
2020-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluoroscopy; Adverse Effect, Radiation Exposure

Keywords

endoscopy, fluoroscopy, radiation exposure

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.

Interventions

RADIATIONRadiation exposure

Radiation exposure via Eview Fluoroscopy machine.

Sponsors

AdventHealth
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Degree of exposure measured by Dap meter and cumulative air KERMA1 dayMeasurement 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026