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

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04161924
• Other study ID #: HSC-MS-18-0527
• Status: Completed
• Start date: December 6, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: June 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 30, 2019
• Est. primary completion date: June 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Diagnostic Test:
• 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 conventional processing
X-ray imaging without physical grid using conventional processing
• X-ray imaging without physical grid using experimental SimGrid offline processing
X-ray imaging without physical grid using experimental SimGrid offline processing

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Samsung Electronics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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