Utilization of Simulated Grid (SimGrid™) Technology for the Reduction of Ionizing Radiation Dose on X-ray Examination in Obese Patients

Study Overview
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Brief Summary
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The purpose of this research study is to learn if a new imaging processing technique called Simulated grid (SimGrid™) will help in getting better quality X-ray images in obese subjects. The GM85 digital radiography machine will be used to obtain X-ray images.

Official Title
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Utilization of Simulated Grid (SimGrid™) Technology for the Reduction of Ionizing Radiation Dose on X-ray Examination in Obese Patients

Conditions
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Obesity, Morbid

Intervention / Treatment
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* Diagnostic Test: X-ray imaging with physical grid using conventional processing
* Diagnostic Test: X-ray imaging without physical grid using conventional processing
* Diagnostic Test: X-ray imaging without physical grid using experimental SimGrid offline processing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obese adult volunteers with Body-Mass Index (BMI) exceeding 30 subjects that require at least one X-ray for continuation of care Exclusion Criteria: subject who is known to have lung disease(s) which would interfere with the interpretation of the chest radiography image subject who is pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| X-ray imaging with physical grid using conventional processing<br> | Diagnostic Test: X-ray imaging with physical grid using conventional processing<br>* X-ray imaging with physical grid using conventional processing<br>* Other names: GM85;|
| X-ray without physical grid using conventional processing<br> | Diagnostic Test: X-ray imaging without physical grid using conventional processing<br>* X-ray imaging without physical grid using conventional processing<br>* Other names: GM85;|
| X-ray imaging without physical grid using experimental SimGrid<br> | Diagnostic Test: X-ray imaging without physical grid using experimental SimGrid offline processing<br>* X-ray imaging without physical grid using experimental SimGrid offline processing<br>* Other names: GM85;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image quality of conventional grid versus SimGrid using 5 point Likert scale | Relative image quality will be assessed using a 5 point Likert scale ranging from -2 to +2 with -2 indicating better image quality with conventional grid and +2 indicating better image quality with SimGrid. | baseline | 
| Image quality of non-grid versus SimGrid using 5 point Likert scale | Relative image quality will be assessed using a 5 point Likert scale ranging from -2 to +2 with -2 indicating better image quality with non-grid and +2 indicating better image quality with SimGrid. | baseline |