UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013629 |
|---|---|
| Receipt number | R000015684 |
| Scientific Title | Injection laryngoplasty using basic fibroblast growth factor for the treatment of deficient glottal closure |
| Date of disclosure of the study information | 2014/04/04 |
| Last modified on | 2016/04/04 16:53:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Injection laryngoplasty using basic fibroblast growth factor for the treatment of deficient glottal closure
Acronym
Injection laryngoplasty using basic fibroblast growth factor for the treatment of deficient glottal closure
Scientific Title
Injection laryngoplasty using basic fibroblast growth factor for the treatment of deficient glottal closure
Scientific Title:Acronym
Injection laryngoplasty using basic fibroblast growth factor for the treatment of deficient glottal closure
Region
| Japan |
Condition
Condition
deficient glottal closure
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the effects of bFGF injection for deficient glottal closure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
High speed imaging and acoustic analysis
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
| Medicine |
Interventions/Control_1
basic fibroblastgrowth factor
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
deficiencies in glottal closure
Key exclusion criteria
Patient with the past of the malignant tumor
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Makiyama |
Organization
Nihon university,School of Medicine
Division name
Otorhinolaryngorogy-Head and Neck surgery
Zip code
Address
30-1 Oyaguchi kamithyo,Itabashiku,Tokyo
TEL
03-3972-8111
mak@med.email.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suzuki Hirotaka |
Organization
Nihon university,School of Medicine
Division name
Otorhinolaryngorogy-Head and Neck surgery
Zip code
Address
30-1 Oyaguchi kamithyo,Itabashiku,Tokyo
TEL
03-3972-8111
Homepage URL
hirotaka.0624@gmail.com
Sponsor or person
Institute
Nihon University Surugadai Hospital
Institute
Department
Personal name
Funding Source
Organization
grant-in-aid for scientific research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Institutions
Institutions
駿河台日本大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 04 | Day |
Last modified on
| 2016 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015684
