X-rays; EffectsNCT06542328
Pre-market Verification of Portable X Ray Machines for Lung Diseases and Orthopedic Limb Lesions
An observational study of X-rays; Effects and Chest--Diseases, run by Energy Resources International Co., Ltd. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- X-rays; Effects, Chest--Diseases, Orthopedic Disorder
- What is being tested?
- ERI CVX-air portable X-ray system, Samsung GM85 (K180543) or MobileDaRt Evolution (K080701) and Samsung GC85A (K160997) or Fujifilm FDR Smart X (K212956)
- Type of treatment
- Medical device
- How many people
- 228 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2021to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects suspected of having pulmonary diseases or orthopedic limb disorders.
Who may be able to join
- Patients with lung diseases and orthopedic limb lesions.
- Aged 20 years or older.
- After informed consent, sign the subject consent form.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- ERI CVX-air portable X-ray system, Samsung GM85 (K180543) or MobileDaRt Evolution (K080701), Samsung GC85A (K160997) or Fujifilm FDR Smart X (K212956)
- Keywords
- Portable X ray machine, Extremities, Telemedicie
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonology | Not described Receives: Device: ERI CVX-air portable X-ray system; Device: Samsung GM85 (K180543) or MobileDaRt Evolution (K080701) | |
| Orthopaedic | Not described Receives: Device: ERI CVX-air portable X-ray system; Device: Samsung GC85A (K160997) or Fujifilm FDR Smart X (K212956) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Apr 2021
- Primary completion23 Jun 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for X-rays; EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Energy Resources International Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542328
- Sponsor's protocol ID
- 110A-305
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-market Verification of Portable X Ray Machines for Lung Diseases and Orthopedic Limb
- ClinicalTrials.gov ID
- NCT06542328
- Acronym / sponsor ID
- 110A-305
- Conditions
- X-rays; Effects, Chest--Diseases, Orthopedic Disorder
- Keywords
- Portable X ray machine, Extremities, Telemedicie
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Energy Resources International Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonology | – | Device: ERI CVX-air portable X-ray system, Device: Samsung GM85 (K180543) or MobileDaRt Evolution (K080701) |
| Orthopaedic | – | Device: ERI CVX-air portable X-ray system, Device: Samsung GC85A (K160997) or Fujifilm FDR Smart X (K212956) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects suspected of having pulmonary diseases or orthopedic limb disorders.
Key inclusion criteria (3 listed)
- Patients with lung diseases and orthopedic limb lesions.
- Aged 20 years or older.
- After informed consent, sign the subject consent form.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERI CVX-air portable X-ray systeminvestigational device | Device | Orthopaedic, Pulmonology |
| Samsung GM85 (K180543) or MobileDaRt Evolution (K080701)The commercially available comparator equipment used for pulmonology. | Device | Pulmonology |
| Samsung GC85A (K160997) or Fujifilm FDR Smart X (K212956)The commercially available comparator equipment used for Orthopaedic. | Device | Orthopaedic |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of X-rays; Effects and Chest--Diseases, run by Energy Resources International Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.