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Japanese

July. 08, 2021

Sept. 03, 2026

jRCTs062210022

Development and evaluation of minimally invasive and dynamic respiratory function testing technology

Development of dynamic X-ray inspection technology

Megumi Hamaguchi

Shimane University Hospital

89-1, Enya-cho, Izumo-shi, Shimane

+81-853-20-2580

hs1219@med.shimane-u.ac.jp

Hamaguchi Megumi

Shimane University Hospital

89-1, Enya-cho, Izumo-shi, Shimane

+81-853-20-2580

hs1219@med.shimane-u.ac.jp

Recruiting

July. 01, 2021

July. 08, 2022
150

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

COPD patients who are admitted or attended the Shimane University Hospital and healthy volunteers(patients without respiratory dysfunction who are admitted or attended the Shimane University Hospital, medical examination participants, Hospital staff medical examination perticipants and students)
For healthy volunteers, those who meet the following 1-3.
1.Persons aged 20 years and over at the time of consent.
2.Persons who are possible labored breathing, resting breathing and breath holding in the standing or lying position.
3.Persons who have received sufficient explanation before participating in this study, and have obtained written consent by their own free will with sufficient understanding.
For COPD patients, those who meet the following 1-4
1.Patients aged 20 years and over at the time of consent.
2.Patients who are possible labored breathing, resting breathing and breath holding in the standing or lying position.
3.Patients who have received sufficient explanation before participating in this study, and have obtained written consent by their own free will with sufficient understanding.
4. Patients who was diagnosis COPD by pulmonorogist.

1.Persons who do not understand the breathing instructions at the time of examination(ex;dementia)
2.Persons with a history of thoracic surgery beyond lobectomy and radiation therapy to the chest.
3.People who are currently admitting or attending the department of respiratory medicine because of respiratory dysfunction other than COPD.
4.Women who are currently pregnant, may be pregnant or breastfeeding.
5.Persons with an implantable pacemaker or implantable defibrillator.
6.Other persons who are judged to be inappropriate by the investigator and the investigator.

20age old over
No limit

Both

Chronic obstructive pulmonary disease

Conducting X-ray dynamic image inspection by a dynamic flat-panel detector system

1.Correlation between dynamic image parameters calculated from dynamic X-ray images in healthy cases and respiratory function test results obtained by spirometry.
2.AUC by ROC analysis of each stage of COPD and non-COPD.

Correlation of dynamic x-ray parameters with mMRC shortness of breath scale and CAT

KONICAMINOLTA, INC.
Shimane University Faculty of Medicine
Shimane University Hospital, Clinical Trial Review Board
89-1, Enya-cho, Izumo-shi, Shimane, 693-8501, Shimane

+81-853-20-2515

kenkyu@med.shimane-u.ac.jp
Approval

May. 24, 2021

No

none

History of Changes

No Publication date
10 Sept. 03, 2026 (this page) Changes
9 May. 07, 2026 Detail Changes
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6 May. 08, 2025 Detail Changes
5 Jan. 16, 2025 Detail Changes
4 Sept. 11, 2023 Detail Changes
3 June. 05, 2023 Detail Changes
2 May. 12, 2023 Detail Changes
1 July. 08, 2021 Detail