UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Type II thyroplasty with titanium bridges for adductor spasmodic dysphonia
Title of the study (Brief title)	Type II thyroplasty forspasmodic dysphonia
Region	Japan

Condition
Condition	adductor spasmodic dysphonia
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect of type II thyroplasty for AdSD
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Measured acoustic outcomes
Key secondary outcomes	Self-perception analysis

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 Maneuver
Interventions/Control_1	operation
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	15 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	adductor spasmodic dysphonia
Key exclusion criteria	other disease
Target sample size	20

Research contact person
Name of lead principal investigator	Tetsuji Sanuki
Organization	Kumamoto Univ
Division name	Otolaryngology
Address	1-1-1 Honjyo, Kumamoto
TEL	096-373-5255
Email	otostl0319@kuh.kumamoto-u.ac.jp

Public contact
Name of contact person	Tetsuji Sanuki
Organization	Kumamoto Univ
Division name	Otolaryngology
Address	1-1-1 Honjyo, Kumamoto
TEL	096-373-5255
Homepage URL
Email	otostl0319@kuh.kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto Univ
Institute
Department

Funding Source
Organization	Kumamoto Univ
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Institutions
Institutions	熊本大学病院

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 26 Day
Anticipated trial start date	2011 Year 12 Month 01 Day
Last follow-up date	2017 Year 05 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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Publication of results	Unpublished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

Management information
Registered date	2011 Year 12 Month 06 Day
Last modified on	2017 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008095