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Mar. 15, 2019 |
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Jan. 01, 2022 |
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jRCTs022180006 |
Study on pulmonary function imaging diagnosis by chest X-ray dynamics photographing with motion picture compatible flat panel detector. Application 1 in emergency area: For pulmonary embolism patients. (Clinical application of chest x-ray dynamic photography) |
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Clinical application of chest x-ray dynamic photography (Clinical application of chest x-ray dynamic photography) |
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Jan. 01, 2022 |
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4 |
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The average age is 73 years (70-76). Three had a definitive diagnosis of pulmonary embolus (all males), and the remaining one was a suspected case (female). |
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Registration was successful at the beginning, but due to the COVID-19 epidemic, the target number of cases was 150, but case registration did not proceed at all and the study was discontinued.. The registration of 4 cases is in 2019. In addition, there were 5 cases in which consent was not reached during the period. |
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No harmful events occurred. |
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Case registration did not proceed and neither the primary nor secondary evaluation could be sufficiently evaluated. In the analysis of 4 cases, In all cases, CT showed embolism (1 of which was bilateral), and 5 area of 4 cases (100%) were able to visually confirm decreased blood flow. This is 100% sensitive, although the number of cases is small. On the other hand, decreased blood flow on the healthy side, which is not an embolic lung, was not visually observed in all cases (3 cases). That is, the specificity was also 100%. Visual judgment was made by 3 people. |
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The number of cases was small and could not be evaluated sufficiently. The sensitivity and specificity was 100% in the analysis of 4 cases. |
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Jan. 01, 2022 |
No |
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No plan |
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https://jrct.mhlw.go.jp/latest-detail/jRCTs022180006 |
SHIMADA JIRO |
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Fukushima Medical University Hospital |
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1 Hikarigaoka, Fukushima City, Fukushima, JAPAN |
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+81-24-547-1111 |
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jshimada@fmu.ac.jp |
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SHIMADA JIRO |
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Fukushima Medical University Hospital |
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1 Hikarigaoka, Fukushima City, Fukushima, JAPAN |
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+81-24-547-1111 |
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jshimada@fmu.ac.jp |
Complete |
Oct. 01, 2018 |
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| Sept. 14, 2018 | ||
| 150 | ||
Interventional |
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single arm study |
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open(masking not used) |
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no treatment control/standard of care control |
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single assignment |
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diagnostic purpose |
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1) Be an adult over 20 years old |
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1) have allergy to the contrast agent |
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| 20age old over | ||
| No limit | ||
Both |
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pulmonary embolism |
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chest X-ray dynamics photographing |
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Sensitivity for diagnosis of pulmonary embolism in measurement method of heart rate variation of permeability of 18 lung fields by chest X-ray dynamic imaging apparatus with contrast CT examination as a reference |
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Specificity for diagnosis of pulmonary embolism in measurement method of heart rate variation of permeability of 18 lung fields by chest X-ray dynamic imaging apparatus with contrast CT examination as a reference |
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| KONICA MINOLTA, CO., Ltd | |
| Applicable |
| KONICA MINOLTA, CO., Ltd | |
| Applicable |
| Fukushima Medical University Certified Review Board | |
| 1 Hikarigaoka, Fukushima city, Hukushima | |
+81-24-547-1825 |
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| fmucrb@fmu.ac.jp | |
| Approval | |
Jan. 16, 2019 |
| UMIN000033644 | |
| Clinical application of chest x-ray dynamic photography 1 |
none |