UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018626 |
|---|---|
| Receipt number | 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 08:58:49 |
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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
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
larynx@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021554
