UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of efficacy and safety in bFGF injection to treat severe vocal fold lesions and vocal fold paralysis.
Acronym	bFGF injection for vocal fold lesions.
Scientific Title	Evaluation of efficacy and safety in bFGF injection to treat severe vocal fold lesions and vocal fold paralysis.
Scientific Title:Acronym	bFGF injection for vocal fold lesions.
Region	Japan

Condition
Condition	vocal fold atrophy,vocal fold sulcus,vocal fold scars,vocal fold paralysis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Safety of bFGF injection for vocal fold
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of Phonological Outcome
Key secondary outcomes	Improvement of vocal fold vibration Improvement of Aerodynamic assessment

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	vocal fold lesions and vocal fold paralysis causing severe hoarseness maintain more than 6 months.
Key exclusion criteria	The subjects with obvious decrease in cardiac function, respiratory function, or hepatic dysfunction in preoperative examinations such as blood sampling, electrocardiogram, or chest x-ray within 3 months. The subjects with vital signs such as heart rate, blood oxygen saturation, and blood pressure are abnormal on the day of surgery. The subjects with other laryngeal disease. The subjects with a history of laryngeal cancer The subjects with drug allergy
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Watanabe Middle name Last name Yusuke
Organization	International University of Health and Welfare
Division name	Tokyo Voice Center
Zip code	107-0052
Address	8-10-16 Akasaka, Minatiku, Tokyo 107-0052, Japan
TEL	03-3402-3151
Email	vetchy2@yahoo.co.jp

Public contact
Name of contact person	1st name Watanabe Middle name Last name Yusuke
Organization	International University of Health and Welfare
Division name	Tokyo Voice Center
Zip code	107-0052
Address	8-10-16 Akasaka, Minatiku, Tokyo 107-0052, Japan
TEL	03-3402-3151
Homepage URL
Email	vetchy2@yahoo.co.jp

Sponsor
Institute	Tokyo Voice Center, International University of Health and Welfare
Institute
Department

Funding Source
Organization	Tokyo Voice Center, International University of Health and Welfare
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	Sanno Hospital
Address	8-10-16 Akasaka, Minatiku, Tokyo 107-0052, Japan
Tel	0285-44-2111
Email	vetchy2@yahoo.co.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	山王病院　国際医療福祉大学東京ボイスセンター　（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 16 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/30734621/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/30734621/
Number of participants that the trial has enrolled	12
Results	Results: No adverse events were recorded. Significant improvements were observed in the maximum phonation time (MPT) and Voice Handicap Index (VHI) after treatment. Multiple injections achieved additional effects. Conclusions and significance: bFGF injection may be a safe and suitable office-based surgery for the alleviation of hoarseness caused by SV based on this preliminary short-term study.
Results date posted	2021 Year 08 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Twelve patients (6 males and 6 females, age range 27-75 years, mean age 51.6 years) diagnosed with bilateral type 2 or type 3 SV without improvement in maximum vocal time (MPT) and Voice Handicap Index (VHI) despite daily voice training including vocal hygiene, relaxation, and vocal function exercises at the Tokyo Voice Center, International University of Health and Welfare. Twelve patients (6 males and 6 females, age range 27-75 years, mean age 51.6 years) diagnosed with SV.
Participant flow	Injection of bFGF into the vocal cords was performed under local anesthesia using 4% lidocaine. After the pharynx and larynx were anesthetized, bFGF (dissolved in 0.5 mL saline) was injected into the SLP using a 23-gauge needle (Varixar; TOP, Tokyo, Japan) while monitoring the larynx. bFGF dosage was equivalent to the concentration used for skin ulcer treatment and was 10% of the maximum The dose of bFGF was equivalent to the concentration used for skin ulcer treatment and was 10% of the maximum value.
Adverse events	None in particular
Outcome measures	Phonological outcomes, MPT, mean airflow rate (MFR), VHI , pitch range (PR), jitter, shimmer, speech fundamental frequency (SFF) and noise-to-harmonic ratio (NHR) were evaluated at >3 or 4 months after bFGF injection.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 31 Day
Date of IRB	2014 Year 06 Month 21 Day
Anticipated trial start date	2015 Year 08 Month 31 Day
Last follow-up date	2018 Year 03 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	....

Management information
Registered date	2015 Year 10 Month 14 Day
Last modified on	2021 Year 08 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021744