Obesity, MorbidNCT04161924
Utilization of Simulated Grid (SimGrid™) Technology for the Reduction of Ionizing Radiation Dose on X-ray Examination in Obese Patients
An observational study of Obesity, Morbid, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- X-ray imaging with physical grid using conventional processing, X-ray imaging without physical grid using conventional processing and X-ray imaging without physical grid using experimental SimGrid offline processing
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2018to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients at clinic who needed chest radiography for continuation of care.
Who may be able to join
- Obese adult volunteers with Body-Mass Index (BMI) exceeding 30
- subjects that require at least one X-ray for continuation of care
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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
- Being tested
- 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 experimental SimGrid offline processing
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-ray imaging with physical grid using conventional processingDiagnostic test
Also called GM85
X-ray imaging with physical grid using conventional processing
X-ray imaging without physical grid using conventional processingDiagnostic test
Also called GM85
X-ray imaging without physical grid using conventional processing
X-ray imaging without physical grid using experimental SimGrid offline processingDiagnostic test
Also called GM85
X-ray imaging without physical grid using experimental SimGrid offline processing
| Study group | Role | What they receive |
|---|---|---|
| X-ray imaging with physical grid using conventional processing | Not described Receives: Diagnostic Test: X-ray imaging with physical grid using conventional processing | |
| X-ray without physical grid using conventional processing | Not described Receives: Diagnostic Test: X-ray imaging without physical grid using conventional processing | |
| X-ray imaging without physical grid using experimental SimGrid | Not described Receives: Diagnostic Test: X-ray imaging without physical grid using experimental SimGrid offline processing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start6 Dec 2018
- Primary completion12 Jun 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Electronics
- Responsible party
- Principal investigator, Roy F Riascos-Castaneda, The University of Texas Health Science Center, Houston
- Investigators
- Roy F Riascos-Castaneda, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161924
- Sponsor's protocol ID
- HSC-MS-18-0527
- Status last verified
- Jun 2020
- First submitted
- 11 Nov 2019
- Last updated
- 16 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Simulated Grid (SimGrid™) Technology for the Reduction of Ionizing Radiation Dose on X-ray Examination in Obese Patients
- ClinicalTrials.gov ID
- NCT04161924
- Acronym / sponsor ID
- HSC-MS-18-0527
- Conditions
- Obesity, Morbid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Samsung Electronics
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients at clinic who needed chest radiography for continuation of care.
Key inclusion criteria (2 listed)
- Obese adult volunteers with Body-Mass Index (BMI) exceeding 30
- subjects that require at least one X-ray for continuation of care
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X-ray imaging with physical grid using conventional processingAlso: GM85X-ray imaging with physical grid using conventional processing | Diagnostic test | X-ray imaging with physical grid using conventional processing |
| X-ray imaging without physical grid using conventional processingAlso: GM85X-ray imaging without physical grid using conventional processing | Diagnostic test | X-ray without physical grid using conventional processing |
| X-ray imaging without physical grid using experimental SimGrid offline processingAlso: GM85X-ray imaging without physical grid using experimental SimGrid offline processing | Diagnostic test | X-ray imaging without physical grid using experimental SimGrid |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy F Riascos-Castaneda, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality of conventional grid versus SimGrid using 5 point Likert scale (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.