UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026056 |
|---|---|
| Receipt number | R000029939 |
| Scientific Title | Evaluation of velopharyngeal closure by 4Dimaging using 320-detector-row computed tomography. |
| Date of disclosure of the study information | 2017/02/10 |
| Last modified on | 2017/02/08 16:57:23 |
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Basic information
Public title
Evaluation of velopharyngeal closure by 4Dimaging using 320-detector-row computed tomography.
Acronym
Evaluation of velopharyngeal closure by 4D-CT.
Scientific Title
Evaluation of velopharyngeal closure by 4Dimaging using 320-detector-row computed tomography.
Scientific Title:Acronym
Evaluation of velopharyngeal closure by 4D-CT.
Region
| Japan |
Condition
Condition
Cleft lip and palate
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By using 4D-CT, the evaluation velopharyngeal closure is performed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The volume change of velopharyngeal closure
Key secondary outcomes
The evaluation score by speech therapist
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Before the operation, 4D-CT is performed during speech in 10 seconds.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with cleft lip and palate who are necessary to evaluate the velopharyngeal closure
Key exclusion criteria
The patients who are providing orthodontic treatment, who can not obtain rest during CT examination
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Kishi |
Organization
Keio University Shool of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353633814
kkishi@a7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Sakamoto |
Organization
Keio University School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353633814
Homepage URL
ysakamoto@z8.keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
慶應義塾大学病院(東京）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 10 | 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
| 2014 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 08 | Day |
Last modified on
| 2017 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029939
