Unique ID issued by UMIN | UMIN000015337 |
---|---|
Receipt number | R000017834 |
Scientific Title | Treatment of vocal fold scar with KP-100LI: phase I/II clinical trial |
Date of disclosure of the study information | 2014/10/03 |
Last modified on | 2017/07/24 19:59:48 |
Treatment of vocal fold scar with KP-100LI: phase I/II clinical trial
KP-100LI for vocal scar
Treatment of vocal fold scar with KP-100LI: phase I/II clinical trial
KP-100LI for vocal scar
Japan |
Vocal fold scar, sulcus
Oto-rhino-laryngology |
Others
NO
To explore safty aspect and vocal outcome by local application of KP-100LI to vocal fold scar and sulcus
Safety
Exploratory
Phase I,II
Safty aspect for KP-100LI
Therapeutic effect in VHI-10, Jitter, MPT, GRBAS, NMWA
Interventional
Single arm
Non-randomized
Open -but assessor(s) are blinded
Uncontrolled
1
Treatment
Medicine |
Transoral application of KP-100LI to the vocal fold
20 | years-old | <= |
65 | years-old | >= |
Male and Female
Diagnosis of vocal fold scar or suclus by stroboscopic exmaination
No orgnic or neurologic disorder on the vocal fold
More than 11 scor of VHI-10
Airway disease caused by burn
History of malignant diseases
Pregnant woman
Severe systemic diseases
18
1st name | |
Middle name | |
Last name | Shigeru Hirano |
Kyoto University Hospital
Otolaryngology
Sakyo-ku, Kyoto 606-8507
075-751-3731
hirano@ent.kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Shigeru Hirano |
Kyoto University Hospital
Otolaryngology
Sakyo-ku, Kyoto 606-8507
075-751-3731
hirano@ent.kuhp.kyoto-u.ac.jp
Kyoto University Hospital
Institute of Biomedical Research and Innovation
Ministry of Health and Welfare
NO
2014 | Year | 10 | Month | 03 | Day |
Unpublished
Completed
2014 | Year | 10 | Month | 03 | Day |
2014 | Year | 10 | Month | 03 | Day |
2016 | Year | 06 | Month | 16 | Day |
2016 | Year | 11 | Month | 04 | Day |
2016 | Year | 11 | Month | 04 | Day |
2017 | Year | 03 | Month | 31 | Day |
2014 | Year | 10 | Month | 03 | Day |
2017 | Year | 07 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017834
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |