Pre-market Verification of Portable X Ray Machines for Lung Diseases and Orthopedic Limb Lesions
NCT ID: NCT06542328
Last Updated: 2024-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
228 participants
OBSERVATIONAL
2021-04-01
2022-08-31
Brief Summary
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Currently sold X ray machines in market for hospital are stationary or big size portable, it is not easy for carrying to use and occupied a large space for installation and storage, beside that, CVXair is a small and light machine within 3.2KG and has extremely low dosage. It is the reason we expect to use CVXair as a convenient X ray machine with low radiation dosage for X ray image diagnosis clinically.
This trial has an expected trial period in two years, the accepted patients are limited to thoracic and orthopedics patients no matter out hospital or in hospital. The accepted patients upper limitation number is 123 respectively. The selected patient will be taken X ray shot in same area and position both by CVXair and market sold machine, the images then will be interpreted by 2 qualified radiologist in different biological structure and specified diseases. Then the process will be given by a suitable test score.
The test result will be calculated by defined index for comparing with the market sold X ray machines, and finally we will base on the result to state the machine is equivalent or not by the market sold X ray machines.
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Pulmonology
ERI CVX-air portable X-ray system
investigational device
Samsung GM85 (K180543) or MobileDaRt Evolution (K080701)
The commercially available comparator equipment used for pulmonology.
Orthopaedic
ERI CVX-air portable X-ray system
investigational device
Samsung GC85A (K160997) or Fujifilm FDR Smart X (K212956)
The commercially available comparator equipment used for Orthopaedic.
Interventions
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ERI CVX-air portable X-ray system
investigational device
Samsung GM85 (K180543) or MobileDaRt Evolution (K080701)
The commercially available comparator equipment used for pulmonology.
Samsung GC85A (K160997) or Fujifilm FDR Smart X (K212956)
The commercially available comparator equipment used for Orthopaedic.
Eligibility Criteria
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Inclusion Criteria
* Aged 20 years or older.
* After informed consent, sign the subject consent form.
Exclusion Criteria
* Pregnant women (female subjects of childbearing potential, undergo pregnancy testing prior to irradiation to exclude the risk of pregnancy).
* Other individuals deemed unsuitable for inclusion in the clinical trial upon physician assessment.
20 Years
ALL
No
Sponsors
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Energy Resources International Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Changhua Christian Hospital
Changhua, Changhua County, Taiwan
Countries
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Other Identifiers
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110A-305
Identifier Type: -
Identifier Source: org_study_id
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