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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05440435
Other study ID # DR001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2022

Study information

Verified date September 2022
Source General Hospital of Chinese Armed Police Forces
Contact Rongrong Hua, Doctor
Phone 0086-15810159356
Email huarongrong1011@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In the high cold environment, mobile digital radiography (DR) is used to collect the imaging of bone injury patients, and the artificial intelligence diagnosis module is used to diagnose the injury. The quality of images obtained by mobile or conventional DR and the consistency between artificial intelligence and pure artificial diagnosis will be analyzed respectively. Finally, the application value of mobile DR loaded with artificial intelligence diagnosis function in high cold environment is determined.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 31, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Patients with new bone injury Exclusion Criteria: - Life threatening. - Head injury and fracture. - There are congenital malformations in the bone injury site.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
digital radiography (DR)
Patients with bone injury received routine and mobile DR sequential examination.

Locations

Country Name City State
China Center A Beijing Beijing
China Xucheng He Neimeng
China Center C Xinjiang
China Center Xizang

Sponsors (1)

Lead Sponsor Collaborator
Rongrong Hua

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The image quality rating scale score. There are 24 entries in the image quality rating scale with a total score of 100 points. According to the score, there are 4 grades (A. =90; B. 80-89; C. 70-79; D. <70), among which D is unqualified. Immediately after inclusion in the study.
Primary Difference of fracture detection rate (sensitivity and specificity) between artificial intelligence and expert diagnosis. Sensitivity is the percentage of individuals with bone injury who diagnosed by artificial intelligence or experts. Specificity is the percentage of those without bone injury who have normal diagnosis results. Immediately after the diagnosis is completed.
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