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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03935737
Enrollment
40
Registered
2019-05-02
Start date
2018-10-26
Completion date
2019-03-22
Last updated
2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest X-ray for Clinical Evaluation

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.

Interventions

DIAGNOSTIC_TESTFull Dose Chest X-Ray

Full dose X ray at Day 1

DIAGNOSTIC_TESTLow Dose Chest X-Ray

Low dose X ray within 3 months from full dose

Sponsors

Samsung Electronics
CollaboratorINDUSTRY
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Image Quality as assessed by the Bureau of Radiological Health (BRH) method based scoring system-Anatomic landmarkbaselineThe BRH anatomic landmark score ranges from 0 to 100 with higher scores indicating better quality.
Image Quality as assessed by the Bureau of Radiological Health (BRH) method based scoring system-Physical parametersbaselineThe BRH physical parameters score ranges from 0 to 100 with higher scores indicating better quality.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026