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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

Validation of a New Post Image Processing Engine (S-Vue™) for the Reduction of Ionizing Radiation Dose on X-ray Examination in Pediatric Patients

Clinicaltrials.gov identifier NCT03935737

Recruitment Status Completed

First Posted May 2, 2019

Last update posted March 24, 2020

Study Description

Brief summary:

The purpose of this study is to compare X-ray images obtained using the GM85 digital radiography machine at the standard full dose to X-ray images obtained using the GM85 digital radiography machine along with the Samsung S-Vue system, which is a image post-processing engine that allows images to be obtained using a lower dose. The study also aims to determine the lowest dose of radiation that can be used to get a good, readable x-ray of the chest in pediatric patients using Samsung S-Vue system.

  • Condition or Disease:Chest X-ray for Clinical Evaluation
  • Intervention/Treatment: Diagnostic Test: Full Dose Chest X-Ray
    Diagnostic Test: Low Dose Chest X-Ray
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Actual Enrollment: 40 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Validation of a New Post Image Processing Engine (S-Vue™) for the Reduction of Ionizing Radiation Dose on X-ray Examination in Pediatric Patients
  • Actual Study Start Date: October 2018
  • Actual Primary Completion Date: March 2019
  • Actual Study Completion Date: March 2019
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Full dose Chest X-Ray
Subjects will receive a full (standard) dose chest X-ray at Day 1.
Diagnostic Test: Full Dose Chest X-Ray
Full dose X ray at Day 1
: Low dose Chest X-Ray
Subjects will receive a follow up X-ray at at a lower dose within 3 months after the first dose.
Diagnostic Test: Low Dose Chest X-Ray
Low dose X ray within 3 months from full dose
Outcome Measures
  • Primary Outcome Measures: 1. Image Quality as assessed by the Bureau of Radiological Health (BRH) method based scoring system-Anatomic landmark [ Time Frame: baseline ]
    The BRH anatomic landmark score ranges from 0 to 100 with higher scores indicating better quality.
  • 2. Image Quality as assessed by the Bureau of Radiological Health (BRH) method based scoring system-Anatomic landmark [ Time Frame: within 3 months ]
    The BRH anatomic landmark score ranges from 0 to 100 with higher scores indicating better quality.
  • 3. Image Quality as assessed by the Bureau of Radiological Health (BRH) method based scoring system-Physical parameters [ Time Frame: baseline ]
    The BRH physical parameters score ranges from 0 to 100 with higher scores indicating better quality.
  • 4. Image Quality as assessed by the Bureau of Radiological Health (BRH) method based scoring system-Physical parameters [ Time Frame: within 3 months ]
    The BRH physical parameters score ranges from 0 to 100 with higher scores indicating better quality.
Eligibility Criteria
  • Ages Eligible for Study: 1 to 15 Month (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Patients seen in clinic.
Criteria

Inclusion Criteria:

- Standard weight/height outpatients who require two X-ray exams within 3 months in the
US

- BMI is >5% and < 85% for participants over the age of 2;for participants less than 2 weight for length will be measured Exclusion Criteria: - Obese and underweight children as defined as BMI ,85% according the World
Health Organization growth chart for participants over 2 years of age; and for
participants less than 2 years of age,weight for length will be measured

Contacts and Locations
Contacts
Locations

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

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Samsung Electronics

Investigators

Principal Investigator: Susan D John, MD The University of Texas Health Science Center, Houston

More Information
  • Responsible Party: The University of Texas Health Science Center, Houston
  • ClinicalTrials.gov Identifier: NCT03935737 History of Changes
  • Other Study ID Numbers: HSC-MS-18-0348
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: March 24, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • 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.: Yes