Pre-market Verification of Portable X Ray Machines for Lung Diseases and Orthopedic Limb Lesions

Energy Resources International Co., Ltd.228 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

228

Conditions

X-rays; Effects Chest--Diseases Orthopedic Disorder

ERI CVX-air portable X-ray systemDEVICE

investigational device

Samsung GM85 (K180543) or MobileDaRt Evolution (K080701)DEVICE

The commercially available comparator equipment used for pulmonology.

Samsung GC85A (K160997) or Fujifilm FDR Smart X (K212956)DEVICE

The commercially available comparator equipment used for Orthopaedic.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with lung diseases and orthopedic limb lesions. * Aged 20 years or older. * After informed consent, sign the subject consent form. Exclusion Criteria: * Patients under the age of 20 years. * 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.

Outcomes

Primary Outcomes

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.