UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014586 |
|---|---|
| Receipt number | R000016970 |
| Scientific Title | Cliical study for Pharyngeal Video Scope National Hospital Organization Nagoya-Tokyo Oral Pharyngeal Scopic Study 2013 |
| Date of disclosure of the study information | 2014/07/18 |
| Last modified on | 2022/12/13 11:30:24 |
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Basic information
Public title
Cliical study for Pharyngeal Video Scope
National Hospital Organization Nagoya-Tokyo Oral Pharyngeal Scopic Study 2013
Acronym
NTOP2013
Scientific Title
Cliical study for Pharyngeal Video Scope
National Hospital Organization Nagoya-Tokyo Oral Pharyngeal Scopic Study 2013
Scientific Title:Acronym
NTOP2013
Region
| Japan |
Condition
Condition
Any type of condition to observe oropharynx.
Classification by specialty
| Medicine in general | Neurology | Pediatrics |
| Oto-rhino-laryngology | Oral surgery | Plastic surgery |
| Emergency medicine | Intensive care medicine | Dental medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the safety and usefulness by a physician.
Basic objectives2
Others
Basic objectives -Others
Evaluate the safety and usefulness by patient, patient's family, nurse,Speech pathologist, and other physicians.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Determine the Safety and Efficacy
5th Grade
(evaluated by physician)
Key secondary outcomes
Determine the Safety and Efficacy
5th Grade
(evaluated by medical stuff and patient and patient's family)
)
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients necessary to observe pharyngeal cavity.
Key exclusion criteria
could not communicate to get informed consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Tsunoda |
Organization
National Hospital Organization
Tokyo Medical Center
Division name
Artificial Organs Medical Device Creation
Zip code
152-8902
Address
2-5-1, Higashigaoka, Meguroku, Tokyo
TEL
03-3411-0111
tsunodakoichi@kankakuki.go.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Tsunoda |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Artificial Organs Medical Device Creation
Zip code
152-8902
Address
2-5-1, Higashigaoka, Meguroku, Tokyo
TEL
03-3411-0111
Homepage URL
onseishitumon@kankakuki.go.jp
Sponsor or person
Institute
National Hospital Organization, Nagoya Medical Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare.
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
e National Hospital Organization Tokyo Medical Center Research Ethics Committee
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo, 152-8902, Japan
Tel
03-3411-0111
koichi.tsunoda@kankakuki.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
| 2014 | Year | 07 | Month | 18 | Day |
Related information
URL releasing protocol
http://doi.org/10.18926/AMO/56381
Publication of results
Published
Result
URL related to results and publications
http://doi.org/10.18926/AMO/56381
Number of participants that the trial has enrolled
150
Results
Tsunoda K, Kobayashi R, Kada A, Saito AM, Misawa H, Horibe K, Goto F, Tsunoda A, Sasaki T, Takanosawa M, Nishino H, Kondoh K, Sugiyama Y, Hisa Y. Development of an Oropharyngeal Scope with an Integrated Tongue Depressor: NTOP2013 Study. Acta Med Okayama. 2018 Dec;72(6):611-614. doi: 10.18926/AMO/56381.
Results date posted
| 2022 | Year | 12 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
(i) inpatients or outpatients who
required observation and treatment of the oral cavity,palate, and pharynx
Participant flow
Evaluation by the attending doctors and display viewers (doctors and medical staffs).
And Evaluation by patients and their families
Adverse events
None
Outcome measures
The primary endpoint is evaluation by the doctors who use the investigational device as an oral laryngoscope.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 23 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 23 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 29 | Day |
Other
Other related information
Ask physicians and medical staff, alos patients and their families, to evaluate the observation, recording, moitering, susefulness, and safety.
Management information
Registered date
| 2014 | Year | 07 | Month | 18 | Day |
Last modified on
| 2022 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016970
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| Registered date | File name |
| Research case data | |
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