Radiation Exposure Assessment in Fluoroscopy

NCT ID: NCT03985488

Last Updated: 2020-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-06

Study Completion Date

2020-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Fluoroscopy; Adverse Effect Radiation Exposure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Eview Fluoroscopy Machine

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

Radiation exposure

Intervention Type RADIATION

Radiation exposure via Eview Fluoroscopy machine.

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 exposure

Intervention Type RADIATION

Radiation exposure via Eview Fluoroscopy machine.

Interventions

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Radiation exposure

Radiation exposure via Eview Fluoroscopy machine.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AdventHealth

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shyam Varadarajulu, MD

Role: PRINCIPAL_INVESTIGATOR

AdventHealth

Locations

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Center for Interventional Endoscopy

Orlando, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32195731 (View on PubMed)

Other Identifiers

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1434665

Identifier Type: -

Identifier Source: org_study_id

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