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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

NCT03935737 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2020-03-24

No results posted yet for this study

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.

Conditions

  • Chest X-ray for Clinical Evaluation

Interventions

DIAGNOSTIC_TEST

Full Dose Chest X-Ray

Full dose X ray at Day 1

DIAGNOSTIC_TEST

Low Dose Chest X-Ray

Low dose X ray within 3 months from full dose

Sponsors & Collaborators

  • Samsung Electronics

    collaborator INDUSTRY

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Susan D John, MD · The University of Texas Health Science Center, Houston

Eligibility

Min Age
1 Month
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-26
Primary Completion
2019-03-22
Completion
2019-03-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03935737 on ClinicalTrials.gov