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

June 11, 2020 updated by: Roy F Riascos-Castaneda, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
X-ray imaging with physical grid using conventional processing
Diagnostic test: X-ray imaging with physical grid using conventional processing
X-ray imaging with physical grid using conventional processing
Other Names:
  • GM85
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 conventional processing
Other Names:
  • GM85
X-ray imaging without physical grid using experimental SimGrid
Diagnostic test: X-ray imaging without physical grid using experimental SimGrid offline processing
X-ray imaging without physical grid using experimental SimGrid offline processing
Other Names:
  • GM85

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Samsung Electronics

Investigators

  • Principal Investigator: Roy F Riascos-Castaneda, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2018

Primary Completion (Actual)

June 12, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

November 11, 2019

First Submitted That Met QC Criteria

November 11, 2019

First Posted (Actual)

November 13, 2019

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-18-0527

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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