UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047792 |
|---|---|
| Receipt number | R000054488 |
| Scientific Title | Therapeutic effects of steroid injection for benign vocal fold lesion |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2022/05/18 16:12:31 |
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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
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
kanatake@omiya.jichi.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054488
