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

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 Overview

• Status: Completed
• Conditions: Orthopedic Disorder; Chest--Diseases; X-rays; Effects
• Intervention / Treatment: Device: ERI CVX-air portable X-ray system; Device: Samsung GM85 (K180543) or MobileDaRt Evolution (K080701); Device: Samsung GC85A (K160997) or Fujifilm FDR Smart X (K212956)

• Study Type: Observational
• Enrollment (Actual): 228

Contacts and Locations

Study Locations

• Taiwan
  • Changhua County
    • Changhua City, Changhua County, Taiwan, 500
      • Changhua Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects suspected of having pulmonary diseases or orthopedic limb disorders.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pulmonology	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.
Orthopaedic	Device: ERI CVX-air portable X-ray system; investigational device; Device: Samsung GC85A (K160997) or Fujifilm FDR Smart X (K212956); The commercially available comparator equipment used for Orthopaedic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.

Collaborators and Investigators

• Sponsor: Energy Resources International Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): June 23, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: August 4, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 4, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Extremities; Portable X ray machine; Telemedicie
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Musculoskeletal Diseases
• Other Study ID Numbers: 110A-305

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No