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

NCT06542328 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 228

Last updated 2024-08-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Energy Resources International Co., Ltd.

    lead INDUSTRY

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-06-23
Completion
2022-08-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06542328 on ClinicalTrials.gov