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

Completed

• Conditions: Obesity, Morbid
• Interventions: Diagnostic Test: X-ray imaging with physical grid using conventional processing; Diagnostic Test: X-ray imaging without physical grid using experimental SimGrid offline processing; Diagnostic Test: X-ray imaging without physical grid using conventional processing

• Registration Number: NCT04161924
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-06
• Primary Completion: 2019-06-12
• Study Completion: 2019-09-30
• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-11
• Study First Posted: 2019-11-13
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-11
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
X-ray imaging with physical grid using conventional processing	X-ray imaging with physical grid using conventional processing	-
X-ray imaging without physical grid using experimental SimGrid	X-ray imaging without physical grid using experimental SimGrid offline processing	-
X-ray without physical grid using conventional processing	X-ray imaging without physical grid using conventional processing	-

Primary Outcome Measures

Name	Time	Method
Image quality of conventional grid versus SimGrid using 5 point Likert scale	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.
Image quality of non-grid versus SimGrid using 5 point Likert scale	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.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States