Radiation Exposure Assessment in Fluoroscopy

NCT03985488 | Completed

• 1 other identifier: 1434665
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fluoroscopy; Adverse Effect; Radiation Exposure

Keywords

endoscopy; fluoroscopy; radiation exposure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Eview Fluoroscopy Machine

The Eview Fluoroscopy Machine is the standard of care fluoro machine used in endoscopy.

Radiation: Radiation exposure

Fluoroshield Device

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

Interventions

Radiation exposure RADIATION

Radiation exposure via Eview Fluoroscopy machine.

Eview Fluoroscopy Machine; Fluoroshield Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is any patient that is having an endoscopy with fluoroscopy at the site.

You may qualify if:

• years and older
• Having an endoscopy with fluoroscopy

You may not qualify if:

• Less than 18 years of age
• Not having an endoscopy with fluoroscopy

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

Center for Interventional Endoscopy

Orlando, Florida, 32803, United States

Location

Related Publications (1)

• 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.

  PMID: 32195731 DERIVED

MeSH Terms

Interventions

Radiation Exposure

Intervention Hierarchy (Ancestors)

Radiation; Physical Phenomena; Environmental Exposure; Environmental Pollution; Public Health; Environment and Public Health

Study Officials

• Shyam Varadarajulu, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 13, 2019
• Study Start: May 6, 2019
• Primary Completion: October 31, 2019
• Study Completion: January 31, 2020
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)