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Completed

NCT Number: NCT04161924

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

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.

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Key information

Conditions

Obesity, Morbid Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

X-ray imaging with physical grid using conventional processing

Diagnostic Test

X-ray imaging with physical grid using conventional processing

Other names: GM85

X-ray imaging without physical grid using conventional processing

Diagnostic Test

X-ray imaging without physical grid using conventional processing

Other names: GM85

X-ray imaging without physical grid using experimental SimGrid offline processing

Diagnostic Test

X-ray imaging without physical grid using experimental SimGrid offline processing

Other names: GM85

Primary outcomes

  1. Image quality of conventional grid versus SimGrid using 5 point Likert scale

    Time frame: baseline

    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.

  2. Image quality of non-grid versus SimGrid using 5 point Likert scale

    Time frame: baseline

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Samsung Electronics

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 13, 2019
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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