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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010937
Receipt No. 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

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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
Email 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
Email dsano@yokohama-cu.ac.jp

Sponsor
Institute Department of Otorhinolaryngology, Head and Neck Surgery, Yokohama City University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012792

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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