Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542328
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Pre-market Verification of Portable X Ray Machines for Lung Diseases and Orthopedic Limb Lesions
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pre-market Verification of Portable X Ray Machines for Lung Diseases and Orthopedic Limb
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 32KG 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
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 32KG 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None