UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042902 |
|---|---|
| Receipt number | R000048972 |
| Scientific Title | Research on motion management and tongue compression by new developed mouthpiece for radiotherapy |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2021/04/13 16:15:22 |
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Basic information
Public title
Research on motion management and tongue compression by new developed mouthpiece for radiotherapy
Acronym
Research on the usefulness of a new mouthpiece for radiotherapy
Scientific Title
Research on motion management and tongue compression by new developed mouthpiece for radiotherapy
Scientific Title:Acronym
Research on the usefulness of a new mouthpiece for radiotherapy
Region
| Japan |
Condition
Condition
Cartinoma of maxillary sinus
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the usefulness of a radiotherapy bite block for motion suppression and tongue depression
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of positional displacement caused by body movement during fixation by the head and neck shell is measured with a cine MRI image.
Key secondary outcomes
Tongue compression function with mouthpiece
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
Cine MRI imaging is performed by fixing with a head and neck shell and wearing a mouthpiece
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 and Female
Key inclusion criteria
Healthy adult
Key exclusion criteria
When MRI is contraindicated, the subject has dentures or moving teeth, or the subject is claustrophobic
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Katsumasa |
| Middle name | |
| Last name | Nakamura |
Organization
Hamamatsu University Scholl of Medicine
Division name
Department of Radiation Oncology
Zip code
431-3192
Address
Handayama 1-20-1, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2242
nakam@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masataka |
| Middle name | |
| Last name | Sakamoto |
Organization
Hamamatsu University School of Medicine
Division name
Cooperative Major in Medical Photonics
Zip code
431-3192
Address
Handayama 1-20-1, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2784
Homepage URL
skmt@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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, Shizuoka, 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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | 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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 05 | Day |
Last modified on
| 2021 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048972
