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

Energy Resources International Co., Ltd.

Status

Completed

Conditions

Orthopedic Disorder

Chest--Diseases

X-rays; Effects

Treatments

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)

Study type

Observational

Funder types

Industry

Identifiers

NCT06542328

110A-305

Details and patient eligibility

About

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.

Enrollment

228 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.