UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Injection laryngoplasty using basic fibroblast growth factor for the treatment of deficient glottal closure
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kiyoshi Makiyama
Organization	Nihon university,School of Medicine
Division name	Otorhinolaryngorogy-Head and Neck surgery
Address	30-1 Oyaguchi kamithyo,Itabashiku,Tokyo
TEL	03-3972-8111
Email	mak@med.email.ne.jp

Public contact
Name of contact person	Suzuki Hirotaka
Organization	Nihon university,School of Medicine
Division name	Otorhinolaryngorogy-Head and Neck surgery
Address	30-1 Oyaguchi kamithyo,Itabashiku,Tokyo
TEL	03-3972-8111
Homepage URL
Email	hirotaka.0624@gmail.com

Sponsor
Institute	Nihon University Surugadai Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000015684