Unique ID issued by UMIN | UMIN000025472 |
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Receipt number | R000029318 |
Scientific Title | Clinical study for Pharyngeal Video Scope Type-2 National Hospital Organization Nagoya-Tokyo Oral Pharyngeal Scopic Study 2016 |
Date of disclosure of the study information | 2016/12/29 |
Last modified on | 2022/12/13 11:20:19 |
Clinical study for Pharyngeal Video Scope Type-2
National Hospital Organization Nagoya-Tokyo Oral Pharyngeal Scopic Study 2016
NTOP2016
Clinical study for Pharyngeal Video Scope Type-2
National Hospital Organization Nagoya-Tokyo Oral Pharyngeal Scopic Study 2016
NTOP2016
Japan |
Any type of condition to observe oropharynx.
Medicine in general | Neurology | Geriatrics |
Surgery in general | Pediatrics | Oto-rhino-laryngology |
Oral surgery | Operative medicine | Emergency medicine |
Intensive care medicine | Rehabilitation medicine | Nursing |
Adult | Child |
Others
NO
Evaluate the safety and usefulness by the physician, medical stuff, and patients and
patient's families.
Others
Evaluate the safety and usefulness by patient, patient's family, nurse,Speech pathologist, and other physicians.
Determine the Safety and Efficacy
5th Grade
(evaluated by physician)
Determine the Safety and Efficacy
5th Grade
(evaluated by medical stuff and patient and patient's family)
)
Observational
Not applicable |
Not applicable |
Male and Female
The patients necessary to observe pharyngeal cavity.
Could not communicate to get informed consent
from patients or their guardians.
100
1st name | |
Middle name | |
Last name | Koichi Tsunoda |
National Hospital Organization
Tokyo Medical Center
Artificial Organs Medical Device Creation
2-5-1, Higashigaoka, Meguro-ku, Tokyo
03-3411-0111
tsunodakoichi@kankakuki.go.j
1st name | |
Middle name | |
Last name | Koichi Tsunoda |
National Hospital Organization Tokyo Medical Center
Artificial Organs Medical Device Creation
2-5-1, Higashigaoka, Meguro-ku, Tokyo
03-3411-0111
tsunodakoichi@kankakuki.go.jp
National Hospital Organization, Nagoya Medical Center
AMED
Japanese Governmental office
Japan
NO
国立病院機構 東京医療センター
国立病院機構 名古屋医療センター(予定)
2016 | Year | 12 | Month | 29 | Day |
https://doi.org/10.2739/kurumemedj.MS644003
Published
https://doi.org/10.2739/kurumemedj.MS644003
100
Tsunoda K, Kobayashi R, Kada A, M Saito A, Hanada YU, Misawa H, Horibe K, Chong T, Honda M, Morita Y, Komiyama O. Development of Oropharyngeal Scope Type II with Integrated Tongue Depressor for Examination of the Oropharynx: NTOP2016 Study. Kurume Med J. 2018 Jul 10;64(4):91-95. doi: 10.2739/kurumemedj.MS644003.
2022 | Year | 12 | Month | 13 | Day |
Evaluation by the attending doctors and display viewers (doctors and medical staffs)
Evaluation by patients and their families
None
The primary endpoint is evaluation by the doctors
who use the investigational device as an oral laryngoscope (evaluation items A to G, Table 2).
Secondary endpoints are to understand patient and
family satisfaction (evaluation items H to J, Table 2)
and display viewer satisfaction (doctors and other
medical staff
Completed
2016 | Year | 04 | Month | 12 | Day |
2016 | Year | 05 | Month | 07 | Day |
Ask physicians and medical staff, alos patients and their families, to evaluate the observation, recording, monitoring, usefulness and safety.
2016 | Year | 12 | Month | 29 | Day |
2022 | Year | 12 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029318
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