UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020616
Receipt number R000023800
Scientific Title Examination of the efficacy and the safety in thyroplasty type 1 with titanium plate and arytenoid adduction
Date of disclosure of the study information 2016/01/18
Last modified on 2017/07/20 09:42:32

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Basic information

Public title

Examination of the efficacy and the safety in thyroplasty type 1 with titanium plate and arytenoid adduction

Acronym

thyroplasty type 1 with titanium plate and arytenoid adduction

Scientific Title

Examination of the efficacy and the safety in thyroplasty type 1 with titanium plate and arytenoid adduction

Scientific Title:Acronym

thyroplasty type 1 with titanium plate and arytenoid adduction

Region

Japan


Condition

Condition

unilateral vocal cord paralysis and vocal cord

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy and safety of type 1 thyroplasty using titanium plate and arytenoid adduction

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Changes from baseline in Voice Handicap Index-10(VHI-10) scores at 12 weeks after the surgery

Key secondary outcomes

laryngeal inspection, subjective symptoms, vocal parameters of acoustic and aerodynamic measurements, voice related QOL(VRQOL),postoperative complications


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

titanium plate

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


Not applicable

Gender

Male and Female

Key inclusion criteria

patients with unilateral vocal cord paralysis or vocal cord atrophy who have symptoms of hoarseness and aspiration

Key exclusion criteria

inoperable patients

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Oridate Nobuhiko

Organization

Yokohama City University School of Medicine

Division name

Department of Otorhinolaryngology, Head and Neck Surgery

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa

TEL

045-787-2687

Email

noridate@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Chiba Yoshihiro

Organization

Yokohama City University School of Medicine

Division name

Department of Otorhinolaryngology, Head and Neck Surgery

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa

TEL

045-787-2687

Homepage URL


Email

chiba_y@yokohama-cu.ac.jp


Sponsor or person

Institute

Department of Otorhinolaryngology, Head and Neck Surgery, Yokohama City University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Otorhinolaryngology, Head and Neck Surgery, Yokohama City University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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 01 Month 18 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

Open public recruiting

Date of protocol fixation

2015 Year 12 Month 17 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 17 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 01 Month 18 Day

Last modified on

2017 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023800


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name