臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 07, 2018
Last modified on	April. 01, 2024
Trial ID	jRCTs052180013

Scientific Title	Development of minimally invasive and dynamic inspection technology-respiratory diseases, pulmonary arteries, aortic diseases- (Development of minimally invasive and dynamic inspection technology)
Public Title	Development of minimally invasive and dynamic inspection technology-respiratory diseases, pulmonary arteries, aortic diseases- (Development of minimally invasive and dynamic inspection technology)

Completion date	Mar. 10, 2024
Result actual enrolment	86
Baseline Characteristics	Around 4 weeks from the day of performing dynamic X-ray radiography, there is a history of any or all consultations such as nuclear medicine examination, CT, respiratory function examination (including scheduled) , and after surgical operation, who are determined to take that additional imaging such as X-rays, CT, and nuclear medicine exam.
Participant flow	Although case enrollment was relatively steady until July 2019, after the outbreak of the COVID-19 outbreak, it became difficult to perform respiratory function tests or imaging with large breaths, and additional cases were difficult to enroll after the last case on February 19, 2020. Thereafter, due to the spread of COVID-19 and the failure of the prototype machine, no new cases were added. Among these patients, 12 had obstructive ventilatory failure and 28 had normal pulmonary function, and their individual respiratory function and airway diameter data on dynamic images were analyzed. The mean age was 64 years, 31 males and 9 females.
Adverse events	No occurrence
Outcome measures	Using a dynamic chest radiography system, 12 subjects with obstructive ventilatory disorders and 28 subjects with normal pulmonary function were studied. The tracheal diameter was significantly stenosed in subjects with obstructive ventilatory disorders compared to normal subjects (P < 0.01).When the subjects were divided into a stenosis group (tracheal stenosis rate(TNr)= 41.5 +- 7.7%, n = 9) and a non-stenosis group (TNr= 9.1 +- 7.0%, n = 31, p < 0.01), FEV1%-G and %V25 were significantly smaller in the stenosis group than in the nonstenosis group (p < 0.01).
Brief summary	Dynamic chest radiography systems have shown potential usefulness in the detection and evaluation of obstructive ventilation disorders.
Date of posting of results summaries	April. 01, 2024
Date of the first journal publication of results	Aug. 01, 2020
URL hyperlink(s) related to results and publications	https://www.sciencedirect.com/science/article/pii/S0720048X20303302?via%3Dihub

Plan to share IPD	No
Plan description	none
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs052180013

Contact for Scientific Queries	Name	Sonoda Akinaga
	Affiliation	Shiga University of Medical Science
	Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
	Telephone	+81-77-548-2288
	E-mail	akinaga@belle.shiga-med.ac.jp
Contact for Public Queries	Name	Sonoda Akinaga
	Affiliation	Shiga University of Medical Science
	Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
	Telephone	+81-77-548-2288
	E-mail	akinaga@belle.shiga-med.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		May. 24, 2017
Actual date of first enrollment		May. 24, 2017
Target sample size		100
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Around 4 weeks from the day of performing dynamic X-ray radiography, there is a history of any or all consultations such as nuclear medicine examination, CT, respiratory function examination (including scheduled) , and after surgical operation, who are determined to take that additional imaging such as X-rays, CT, and nuclear medicine exam.
	Exclusion Criteria	Pregnant patient. Patients are judged not to participate in this study by the attending physician.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		respiratory diseases, pulmonary arteries, aortic diseases
Intervention(s)		Development of minimally invasive and dynamic inspection technology
Health Condition(s) Keyword		respiratory diseases, pulmonary arteries, aortic diseases
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Disease detection ability
Secondary Outcome(s)		Correlation with clinical

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	KONICA MINOLTA, INC.
Secondary Sponsor	Not applicable

Source of Monetary Support	KONICA MINOLTA, INC.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Shiga University of Medical Science Clinical Research Review Board
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN , Shiga
Telephone	+81-75-548-3576
E-Mail	hqrec@belle.shiga-med.ac.jp
Approval Status	Approval
Date of approval	Oct. 23, 2018

Secondary ID(s)	UMIN000023875
Issuing Authority	University Hospital Medical Information Network Center

Countries of Recruitment（Except Japan）	Nothing

History of Changes

No	Publication date
11	April. 01, 2024	(this page)	Changes
10	Dec. 23, 2021	Detail	Changes
9	July. 28, 2021	Detail	Changes
8	May. 10, 2021	Detail	Changes
7	April. 05, 2021	Detail	Changes
6	June. 08, 2020	Detail	Changes
5	Mar. 27, 2020	Detail	Changes
4	Jan. 10, 2020	Detail	Changes
3	July. 11, 2019	Detail	Changes
2	May. 10, 2019	Detail	Changes
1	Dec. 07, 2018	Detail

List of change history