UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Treatment for Adductor Spasmodic Dysphonia by Type 2 Thyroplasty using Titanium Bridges
Title of the study (Brief title)	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	Tetsuji Sanuki
Organization	Kumamoto University Hospital
Division name	Department of Otolaryngology-Head and Neck Surgery
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	Tetsuji Sanuki
Organization	Department of Otolaryngology-Head and Neck Surgery,Kumamoto University Hospital
Division name	Office for TS-001 Clinical Trial
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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