UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010937 |
|---|---|
| Receipt number | R000012792 |
| Scientific Title | Evaluation of efficacy and safety in thyroplasty type I with titanium plate |
| Date of disclosure of the study information | 2013/06/17 |
| Last modified on | 2016/03/22 13:27:40 |
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Basic information
Public title
Evaluation of efficacy and safety in thyroplasty type I with titanium plate
Acronym
Thyroplasty type I with titanium plate
Scientific Title
Evaluation of efficacy and safety in thyroplasty type I with titanium plate
Scientific Title:Acronym
Thyroplasty type I with titanium plate
Region
| Japan |
Condition
Condition
unilateral vocal fold paralysis or vocal fold atrophy
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is a better voice improvement after the operation as compared with the silicon block or Gore-tex used now in thyroplasty type I, and examination of the safety of a titanium plate.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Maximum phonation time (MPT)
Key secondary outcomes
GRBAS, vocal parameters of acoustic and aerodynamic measurements, postoperative complications
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
titanium plate
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
| 14 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients worried about symptoms of hoarseness and/or misswallowing because of unilateral vocal fold paralysis or vocal fold atropy
Key exclusion criteria
inoperable patients
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Oridate Nobuhiko |
Organization
Yokohama City University School of Medicine
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2687
noridate@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Sano |
Organization
Yokohama City University School of Medicine
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2687
Homepage URL
http://www.yokohama-cu.ac.jp/fukuhp/section/depts/nose_and_ears.html
dsano@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Otorhinolaryngology, Head and Neck Surgery, Yokohama City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Otorhinolaryngology, Head and Neck Surgery, Yokohama City University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 12 | Day |
Last modified on
| 2016 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012792
