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

NCT04161924 | Completed FDA Device

• 1 other identifier: HSC-MS-18-0527
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

X-ray imaging with physical grid using conventional processing

Diagnostic Test: X-ray imaging with physical grid using conventional processing

X-ray without physical grid using conventional processing

Diagnostic Test: X-ray imaging without physical grid using conventional processing

X-ray imaging without physical grid using experimental SimGrid

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

Interventions

X-ray imaging with physical grid using conventional processing DIAGNOSTIC_TEST

X-ray imaging with physical grid using conventional processing

Also known as: GM85

X-ray imaging with physical grid using conventional processing

X-ray imaging without physical grid using conventional processing DIAGNOSTIC_TEST

X-ray imaging without physical grid using conventional processing

Also known as: GM85

X-ray without physical grid using conventional processing

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

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

Also known as: GM85

X-ray imaging without physical grid using experimental SimGrid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients at clinic who needed chest radiography for continuation of care.

You may qualify if:

• Obese adult volunteers with Body-Mass Index (BMI) exceeding 30
• subjects that require at least one X-ray for continuation of care

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Samsung Electronics: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Roy F Riascos-Castaneda, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 13, 2019
• Study Start: December 6, 2018
• Primary Completion: June 12, 2019
• Study Completion: September 30, 2019
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)