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Radiation Exposure Assessment in Fluoroscopy

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ClinicalTrials.gov Identifier: NCT03985488
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Florida Hospital

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

Condition or disease Intervention/treatment
Fluoroscopy; Adverse Effect Radiation Exposure Radiation: Radiation exposure

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.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Registry of Radiation Exposure Measurement in Procedures Utilizing Fluoroscopy
Actual Study Start Date : May 6, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Eview Fluoroscopy Machine
The Eview Fluoroscopy Machine is the standard of care fluoro machine used in endoscopy.
Radiation: Radiation exposure
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: Radiation exposure
Radiation exposure via Eview Fluoroscopy machine.




Primary Outcome Measures :
  1. Degree of exposure measured by Dap meter and cumulative air KERMA [ Time Frame: 1 day ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study population is any patient that is having an endoscopy with fluoroscopy at the site.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985488


Contacts
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Contact: Shyam Varadarajulu, MD 407.303.2570 Shyam.Varadarajulu.MD@adventhealth.com
Contact: Robin Barron, RN, MSN 407.303.5503 robin.barron@adventhealth.com

Locations
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United States, Florida
Center for Interventional Endoscopy Recruiting
Orlando, Florida, United States, 32803
Contact: Shyam Varadarajulu, MD    407-303-2750    Shyam.Varadarajulu.MD@flhosp.org   
Contact: Robin E Barron-Nelson, RN, MSN    407.303.5503    Robin.Barron@flhosp.org   
Sponsors and Collaborators
Florida Hospital
Investigators
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Principal Investigator: Shyam Varadarajulu, MD AdventHealth

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Responsible Party: Florida Hospital
ClinicalTrials.gov Identifier: NCT03985488     History of Changes
Other Study ID Numbers: 1434665
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Florida Hospital:
endoscopy
fluoroscopy
radiation exposure