Clinical trial NCT03985488: Radiation Exposure Assessment in Fluoroscopy
Official title: Prospective Registry of Radiation Exposure Measurement in Procedures Utilizing Fluoroscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluoroscopy; Adverse Effect
Radiation Exposure
Keywords: endoscopy
fluoroscopy
radiation exposure
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is any patient that is having an endoscopy with fluoroscopy at the site.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Degree of exposure measured by Dap meter and cumulative air KERMA
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Center for Interventional Endoscopy
state: Florida
Study officials:
affiliation: AdventHealth
name: Shyam Varadarajulu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bang JY, Hough M, Hawes RH, Varadarajulu S. Use of Artificial Intelligence to Reduce Radiation Exposure at Fluoroscopy-Guided Endoscopic Procedures. Am J Gastroenterol. 2020 Apr;115(4):555-561. doi: 10.14309/ajg.0000000000000565.