Unique ID issued by UMIN | UMIN000019347 |
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Receipt number | R000021744 |
Scientific Title | Evaluation of efficacy and safety in bFGF injection to treat severe vocal fold lesions and vocal fold paralysis. |
Date of disclosure of the study information | 2015/10/16 |
Last modified on | 2021/08/12 13:17:25 |
Evaluation of efficacy and safety in bFGF injection to treat severe vocal fold lesions and vocal fold paralysis.
bFGF injection for vocal fold lesions.
Evaluation of efficacy and safety in bFGF injection to treat severe vocal fold lesions and vocal fold paralysis.
bFGF injection for vocal fold lesions.
Japan |
vocal fold atrophy,vocal fold sulcus,vocal fold scars,vocal fold paralysis
Oto-rhino-laryngology |
Others
NO
Safety of bFGF injection for vocal fold
Efficacy
Improvement of Phonological Outcome
Improvement of vocal fold vibration
Improvement of Aerodynamic assessment
Observational
Not applicable |
Not applicable |
Male and Female
vocal fold lesions and vocal fold paralysis causing severe hoarseness
maintain more than 6 months.
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
100
1st name | Watanabe |
Middle name | |
Last name | Yusuke |
International University of Health and Welfare
Tokyo Voice Center
107-0052
8-10-16 Akasaka, Minatiku, Tokyo 107-0052, Japan
03-3402-3151
vetchy2@yahoo.co.jp
1st name | Watanabe |
Middle name | |
Last name | Yusuke |
International University of Health and Welfare
Tokyo Voice Center
107-0052
8-10-16 Akasaka, Minatiku, Tokyo 107-0052, Japan
03-3402-3151
vetchy2@yahoo.co.jp
Tokyo Voice Center, International University of Health and Welfare
Tokyo Voice Center, International University of Health and Welfare
Self funding
Sanno Hospital
8-10-16 Akasaka, Minatiku, Tokyo 107-0052, Japan
0285-44-2111
vetchy2@yahoo.co.jp
NO
山王病院 国際医療福祉大学東京ボイスセンター (東京都)
2015 | Year | 10 | Month | 16 | Day |
https://pubmed.ncbi.nlm.nih.gov/30734621/
Published
https://pubmed.ncbi.nlm.nih.gov/30734621/
12
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.
2021 | Year | 08 | Month | 12 | Day |
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.
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.
None in particular
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.
Completed
2015 | Year | 08 | Month | 31 | Day |
2014 | Year | 06 | Month | 21 | Day |
2015 | Year | 08 | Month | 31 | Day |
2018 | Year | 03 | Month | 23 | Day |
....
2015 | Year | 10 | Month | 14 | Day |
2021 | Year | 08 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021744
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