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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018626
Receipt No. R000021554
Scientific Title Treatment for Adductor Spasmodic Dysphonia by Type 2 Thyroplasty using Titanium Bridges
Date of disclosure of the study information 2015/08/10
Last modified on 2017/08/16

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Basic information
Public title Treatment for Adductor Spasmodic Dysphonia by Type 2 Thyroplasty using Titanium Bridges
Acronym Treatment for Adductor Spasmodic Dysphonia by Type 2 Thyroplasty using Titanium Bridges
Scientific Title Treatment for Adductor Spasmodic Dysphonia by Type 2 Thyroplasty using Titanium Bridges
Scientific Title:Acronym Treatment for Adductor Spasmodic Dysphonia by Type 2 Thyroplasty using Titanium Bridges
Region
Japan

Condition
Condition Adductor Spasmodic Dysphonia
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of type 2 thyroplasty using titanium bridges for adductor spasmodic dysphonia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II,III

Assessment
Primary outcomes Change from baseline in VHI-10 scores at 13 weeks after surgery
Key secondary outcomes 1. Changes in VHI-10 scores before and after surgery
2. Changes in VHI scores before and after surgery
3. Changes in VHI subscale scores in the functional (F), (P), and (E)
4. Changes in phonatory function test results before and after surgery
5. Changes in acoustic analysis results
6. Frequency of adverse events and device defects

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 Type 2 Thyroplasty using Titanium Bridges
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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Diagnosis of adductor spasmodic dysphonia by a board certified otorhinolaryngologist certified by the Oto-Rhino-Laryngological Society of Japan, Inc.
2. At least 1 year experience of subjective or objective labored speech production, or pauses on certain sounds, due to adductor spasmodic dysphonia
3. A total score of 20 or more on the Voice Handicap Index-10 (VHI-10)
4. Non-responders to voice therapy performed before informed consent
5. 18 through 80 years of age inclusive at the time of informed consent
6. Written informed consent to participate in this study, provided by patients or their legally acceptable representatives
Key exclusion criteria 1. Dysphagia, laryngeal paralysis, or any structural disorder in the vocal cord
2. Previous surgery for adductor spasmodic dysphonia
3. Local injection of botulinum toxin type A into the intralaryngeal muscles within 6 months before informed consent
4. Serious concomitant diseases
5. Surgery with general anesthesia scheduled during the study period or surgery performed within the past 4 weeks
6. Participation in any other study using any other intervention within 12 weeks before informed consent, or planned participation in such a study during the study period after enrollment in this study
7. Psychiatric disorder requiring treatment, or mental or intellectual disability that may affect the conduct of the study
8. A history of alcoholism or drug abuse
9. A history of hypersensitivity to pure titanium
10. Women who are pregnant or planning to become pregnant during the study period
11. Patients deemed ineligible for this study by the investigator for any other reason
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuji Sanuki
Organization Kumamoto University Hospital
Division name Department of Otolaryngology-Head and Neck Surgery
Zip code
Address 1-1-1 Honjo Chuo-ku Kumamoto 860-8556 Japan
TEL +81-96-373-5255
Email otostl@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuji Sanuki
Organization Department of Otolaryngology-Head and Neck Surgery,Kumamoto University Hospital
Division name Office for TS-001 Clinical Trial
Zip code
Address 1-1-1 Honjo Chuo-ku Kumamoto 860-8556 Japan
TEL +81-96-373-5180
Homepage URL
Email larynx@kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University
Institute
Department

Funding Source
Organization Intractable Disease Research/Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Hokkaido University Hospital
Yokohama City University Hospital
Kyoto University Hospital
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 27-70/2015-03

Institutions
Institutions 国立大学法人熊本大学医学部附属病院(熊本県)/Kumamoto University Hospital,Kumamoto
国立大学法人北海道大学病院(北海道)/Hokkaido University Hospital,Hokkaido
公立大学法人横浜市立大学附属病院(神奈川県)/Yokohama City University,Kanagawa
国立大学法人京都大学医学部附属病院(京都府)/Kyoto University Hospital,Kyoto

Other administrative information
Date of disclosure of the study information
2015 Year 08 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
2015 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 10 Day
Last follow-up date
2017 Year 03 Month 29 Day
Date of closure to data entry
Date trial data considered complete
2017 Year 05 Month 25 Day
Date analysis concluded
2017 Year 06 Month 21 Day

Other
Other related information

Management information
Registered date
2015 Year 08 Month 10 Day
Last modified on
2017 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021554

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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