UMIN-CTR Clinical Trial

Basic information
Public title	Research on the inhibitory effect of an airbag system for abdominal compression on the respiratory movement
Acronym	Research on an airbag system for abdominal compression
Scientific Title	Research on the inhibitory effect of an airbag system for abdominal compression on the respiratory movement
Scientific Title:Acronym	Research on an airbag system for abdominal compression
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of an airbag system for abdominal compression to reduce respiratory movement.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes of diaphragmatic positions during resting expiration and inspiration in the presence or absence of abdominal compressions on cine MRI.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	In the presence or absence of abdominal compressions, cineMRI is performed for about 1 hour.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male
Key inclusion criteria	Healthy adult males
Key exclusion criteria	When MRI is contraindicated
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Katsumasa Middle name Last name Nakamura
Organization	Hamamatsu University School of Medicine
Division name	Department of Radiation Oncology
Zip code	431-3192
Address	Handayama 1-20-1, Higashi-ku, Hamamatsu 431-3192, JAPAN
TEL	053-435-2242
Email	nakam@hama-med.ac.jp

Public contact
Name of contact person	1st name Katsumasa Middle name Last name Nakamura
Organization	Hamamatsu University School of Medicine
Division name	Department of Radiation Oncology
Zip code	431-3192
Address	Handayama 1-20-1, Higashi-ku, Hamamatsu 431-3192, JAPAN
TEL	053-435-2242
Homepage URL
Email	nakam@hama-med.ac.jp

Sponsor
Institute	Department of Radiation Oncology, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Department of Radiation Oncology, Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hamamatsu University School of Medicine
Address	Handayama 1-20-1, Higashi-ku, Hamamatsu 431-3192, JAPAN
Tel	053-435-2680
Email	rinri@hama-med.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	浜松医科大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2020 Year 09 Month 04 Day
Date of IRB	2020 Year 10 Month 12 Day
Anticipated trial start date	2020 Year 12 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry	2022 Year 12 Month 31 Day
Date trial data considered complete	2023 Year 03 Month 31 Day
Date analysis concluded	2023 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 10 Month 21 Day
Last modified on	2020 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048035

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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