NCT06542328

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 228 (actual)
• Sponsor: Energy Resources International Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• X-rays; Effects
• Chest--Diseases
• Orthopedic Disorder

Interventions

Type	Name	Description
DEVICE	ERI CVX-air portable X-ray system	investigational device
DEVICE	Samsung GM85 (K180543) or MobileDaRt Evolution (K080701)	The commercially available comparator equipment used for pulmonology.
DEVICE	Samsung GC85A (K160997) or Fujifilm FDR Smart X (K212956)	The commercially available comparator equipment used for Orthopaedic.

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-06-23
• Completion: 2022-08-31
• First posted: 2024-08-07
• Last updated: 2024-08-07

Locations

1 site across 1 country: Taiwan