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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023570
Receipt No. R000027147
Scientific Title Study on the efficacy and safety of titanium bridge for the adductor type spasmodic dysphonia
Date of disclosure of the study information 2016/09/01
Last modified on 2017/09/21

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Basic information
Public title Study on the efficacy and safety of titanium bridge for the adductor type spasmodic dysphonia
Acronym Study on the efficacy and safety of titanium bridge for the adductor type spasmodic dysphonia
Scientific Title Study on the efficacy and safety of titanium bridge for the adductor type spasmodic dysphonia
Scientific Title:Acronym Study on the efficacy and safety of titanium bridge for the adductor type spasmodic dysphonia
Region
Japan

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

Objectives
Narrative objectives1 Purpose is to validate the safety and efficacy of more breaking difficult titanium bridge
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The amount of change before and after surgery of VHI-10
Preoperative and postoperative 13 weeks
Key secondary outcomes

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 Thyroplasty type 2 using a titanium bridge
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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients specialist of Japan Otolaryngology Society certification was diagnosed of Adductor type spasmodic dysphonia
2.Patients effort of utterance or voice interruption of more than 1 year
subjective or objective
3.90-year-old following of patients from 20 years of age on consent acquisition date
4.Document consent at the free will of the patients can be obtained
Key exclusion criteria 1.Dysphagia, Laryngeal paralysis or Organic lesion in the vocal cord
2.Patients with serious complications
3.Patients with a history of mental illness, mental disorders, intellectual disability, alcoholism and drug abuse in need of such treatment.
4.Hypersensitivity history with respect to pure titanium
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yorihisa Orita
Organization kumamotoUniversityHospital
Division name Department of Otolaryngology-Head and Neck Surgery
Zip code
Address 1-1-1, Honjo Chuo-ku, Kumamoto-shi Kumamoto, Japan
TEL 096-373-5255
Email jibika-ikyoku@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kouhei Nishimoto
Organization kumamotoUniversityHospital
Division name Department of Otolaryngology-Head and Neck Surgery
Zip code
Address 1-1-1, Honjo Chuo-ku, Kumamoto-shi Kumamoto, Japan
TEL 096-373-5255
Homepage URL
Email jibika-ikyoku@kumamoto-u.ac.jp

Sponsor
Institute Department of Otolaryngology-Head and Neck SurgerykumamotoUniversityHospital
Institute
Department

Funding Source
Organization Department of Otolaryngology-Head and Neck SurgerykumamotoUniversityHospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 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 Enrolling by invitation
Date of protocol fixation
2016 Year 08 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 09 Day
Last modified on
2017 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027147

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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