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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042182
Receipt No. R000048035
Scientific Title Research on the inhibitory effect of an airbag system for abdominal compression on the respiratory movement
Date of disclosure of the study information 2020/12/01
Last modified on 2020/10/21

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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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