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

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ClinicalTrials.gov Identifier: NCT03935737
Recruitment Status : Completed
First Posted : May 2, 2019
Last Update Posted : May 27, 2019
Sponsor:
Collaborator:
Samsung Neurologica
Information provided by (Responsible Party):
Susan D John, The University of Texas Health Science Center, Houston

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 Intervention/treatment Phase
Chest X-ray for Clinical Evaluation Diagnostic Test: Full Dose Chest X-Ray Diagnostic Test: Low Dose Chest X-Ray Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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 26, 2018
Actual Primary Completion Date : March 22, 2019
Actual Study Completion Date : March 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays

Arm Intervention/treatment
Active Comparator: 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
Other Name: GM85

Experimental: 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
Other Name: GM85




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.



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Ages Eligible for Study:   1 Month to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ,<5% or >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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935737


Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Samsung Neurologica
Investigators
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Principal Investigator: Susan D John, MD The University of Texas Health Science Center, Houston

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Responsible Party: Susan D John, Professor, 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: May 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No