Artificial Intelligence Clinical Trial
Official title:
Application of Mobile DR in the Diagnosis of Bone Trauma in High Cold Environment
| 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 |
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Center A | Beijing | Beijing |
| China | Xucheng He | Neimeng | |
| China | Center C | Xinjiang | |
| China | Center | Xizang |
| Lead Sponsor | Collaborator |
|---|---|
| Rongrong Hua |
China,
| 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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