An observational study in X-rays; Effects, Chest--Diseases and Orthopedic Disorder, sponsored by Energy Resources International Co., Ltd.. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Energy Resources International Co., Ltd. · Observational
The clinical trial is to evaluate a portable X ray machine (model name: CVXair) for chest and extremities diagnosis, the performance of machine is comparing to the commercial stationary and portable machine both in biological structure way and disease diagnosis way by the image generated.
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.
668 studies on the registry are indexed under Musculoskeletal Diseases; 161 are open to participants now.
This study's enrollment of 228 is above the median of 132 across 208 observational studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →This is the only study on the registry with Energy Resources International Co., Ltd. as lead sponsor.
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Adult subjects suspected of having pulmonary diseases or orthopedic limb disorders.
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Exclusion Criteria:
Device: ERI CVX-air portable X-ray system · Device: Samsung GM85 (K180543) or MobileDaRt Evolution (K080701)
Device: ERI CVX-air portable X-ray system · Device: Samsung GC85A (K160997) or Fujifilm FDR Smart X (K212956)
investigational device
The commercially available comparator equipment used for pulmonology.
The commercially available comparator equipment used for Orthopaedic.
Comparing the investigational device with the control device using Two Parellel-Sample Mean Test for Non-inferiority, the average scores of image quality at 5 anatomical sites.
The average scores (Likert scale，1-4) for image quality at 5 anatomical sites/items generated by the investigational equipment for producing radiographic images of the thorax and limbs in human anatomy, compared to the commercial equipment, were evaluated based on the criteria defined in the study by Cheng Ting Lin et al. (Lin et al., 2020). These scores were assessed for diagnostic utility and level of defects.
Time frame: Only images captured with the trial device and control device within a range of -1 day, 0 day, and 1 day from each other were selected for analysis.
Ran from Apr 2021 to primary completion in Jun 2022, 14 months.
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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