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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | lung cancer | |
Classification by specialty |
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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 |
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Interventions/Control_1 | In the presence or absence of abdominal compressions, cineMRI is performed for about 1 hour. | |
Interventions/Control_2 | ||
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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 |
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Age-upper limit |
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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 |
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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 | ||||||
nakam@hama-med.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |