UMIN-CTR Clinical Trial

Basic information
Public title	Therapeutic effects of steroid injection for benign vocal fold lesion
Acronym	Steroid injection for benign vocal fold lesion
Scientific Title	Therapeutic effects of steroid injection for benign vocal fold lesion
Scientific Title:Acronym	Steroid injection for benign vocal fold lesion
Region	Japan

Condition
Condition	benign vocal fold lesion
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To analyze the efficacy and safety of VFSI to investigate the mechanism underlying its therapeutic effects and determine the conditions in which VFSI will be most effective.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Voice Handicap Index 3-4 months after injection
Key secondary outcomes	maximum phonation time, mean airflow rate, GRBAS scale

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Patients who have undergone intravocal steroid injection therapy since April 1, 2014
Key exclusion criteria	Patients with non-participation statement
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yusuke Middle name Last name Watanabe
Organization	International University of Health and Welfare
Division name	Tokyo Voice Center
Zip code	107-0052
Address	8-10-16 Akasaka Minato-ku Tokyo
TEL	03-3402-3151
Email	nabe@iuhw.ac.jp

Public contact
Name of contact person	1st name Takeharu Middle name Last name Kanazawa
Organization	International University of Health and Welfare
Division name	Tokyo Voice Center
Zip code	107-0052
Address	8-10-16 Akasaka Minato-ku Tokyo
TEL	03-3402-3151
Homepage URL
Email	kanatake@omiya.jichi.ac.jp

Sponsor
Institute	International University of Health and Welfare
Institute
Department

Funding Source
Organization	International University of Health and Welfare Tokyo Voice Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	International University of Health and Welfare
Address	Tokyo Voice Center
Tel	0334023151
Email	kanatake@omiya.jichi.ac.jp

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	2022 Year 06 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	90
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	No longer recruiting
Date of protocol fixation	2019 Year 05 Month 25 Day
Date of IRB	2021 Year 05 Month 25 Day
Anticipated trial start date	2019 Year 05 Month 25 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The results of MPT, MFR, GRBAS scale, PR, Jitter, Shimmer, NHR, VHI, and other voice tests before and after the treatment will be used to statistically examine the degree of improvement, complications, healing days, surgeon, operation time, and presence of underlying diseases.

Management information
Registered date	2022 Year 05 Month 18 Day
Last modified on	2022 Year 05 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054488